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    Clinical Trial Results:
    A Phase 2 Open-Label Study in Infants with Respiratory Syncytial Virus Lower Respiratory Tract Infection, Followed by a Double-blind, Placebo Controlled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)

    Summary
    EudraCT number
    2018-001010-15
    Trial protocol
    HU   PL   BE  
    Global end of trial date
    05 Dec 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jun 2023
    First version publication date
    21 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C5241003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04225897
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    REVC003: Study ID
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Dec 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part A and Part B: To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with Respiratory Syncytial Virus (RSV) lower respiratory tract infection (LRTI).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Malaysia: 7
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Thailand: 9
    Country: Number of subjects enrolled
    Panama: 3
    Country: Number of subjects enrolled
    Spain: 27
    Worldwide total number of subjects
    51
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    43
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study was planned to be conducted in 3 parts: Part A, B and optional part C. Part C was not conducted as part of a reassessment of the clinical development plan for RV521 (sisunatovir); hence, data is not reported for Part C in any section of the results. A total of 51 subjects were enrolled in the study (Part A=19 and Part B=32).

    Period 1
    Period 1 title
    Part A (Screening Visit to Day 7)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1: RV521 1.0 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 1.0 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route on Day 1.

    Arm title
    Cohort 1: RV521 2.0 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.0 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route on Day 1.

    Arm title
    Cohort 1: RV521 2.5 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route on Day 1.

    Arm title
    Cohort 2: RV521 2.0 mg/kg
    Arm description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.0 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route on Day 1.

    Number of subjects in period 1 [1]
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Started
    3
    7
    3
    6
    Completed
    3
    6
    1
    6
    Not completed
    0
    1
    2
    0
         Adverse events
    -
    1
    -
    -
         Parent/legal guardian request
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Total 51 subjects were enrolled (Part A=19 and Part B=32).
    Period 2
    Period 2 title
    Part B (Screening Visit to Day 12)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Cohort 3: Placebo
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered placebo dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of placebo separated by 12 hours orally for 5 days.

    Arm title
    Cohort 3: RSV1 2.5 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of RV521 separated by 12 hours orally for 5 days.

    Arm title
    Cohort 3: RV521 3.5 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 3.5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of RV521 separated by 12 hours orally for 5 days.

    Arm title
    Cohort 3: RV521 5 mg/kg
    Arm description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of RV521 separated by 12 hours orally for 5 days.

    Arm title
    Cohort 4: Placebo
    Arm description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered placebo dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of placebo separated by 12 hours orally for 5 days.

    Arm title
    Cohort 4: RV521 2.5 mg/kg
    Arm description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of RV521 separated by 12 hours orally for 5 days.

    Arm title
    Cohort 5: Placebo
    Arm description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered placebo dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of placebo separated by 12 hours orally for 5 days.

    Arm title
    Cohort 5: RV521 2.5 mg/kg
    Arm description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Sisunatovir
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered RV521 2.5 mg/kg dispersed in a defined volume of permitted suspending diluent via the oral route. Subjects received BID of RV521 separated by 12 hours orally for 5 days.

    Number of subjects in period 2
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Started
    3
    3
    4
    3
    1
    4
    6
    8
    Completed
    3
    3
    4
    2
    1
    4
    6
    8
    Not completed
    0
    0
    0
    1
    0
    0
    0
    0
         Parent/legal guardian request
    -
    -
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: RV521 1.0 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.

    Reporting group title
    Cohort 1: RV521 2.0 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.

    Reporting group title
    Cohort 1: RV521 2.5 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.

    Reporting group title
    Cohort 2: RV521 2.0 mg/kg
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.

    Reporting group values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg Total
    Number of subjects
    3 7 3 6 19
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    1 5 3 6 15
        Children (2-11 years)
    2 2 0 0 4
    Age Continuous
    99999 indicates standard deviation could not be calculated as a single subject was analysed.
    Units: months
        arithmetic mean (standard deviation)
    27.8 ± 5.90 18.1 ± 7.25 9.4 ± 2.46 2.7 ± 1.69 -
    Gender Categorical
    Units: Subjects
        Female
    0 4 2 1 7
        Male
    3 3 1 5 12
    Race
    Units: Subjects
        American Indian or Alaskan Native
    0 0 0 1 1
        Asian
    0 7 0 1 8
        White
    3 0 3 4 10
        Black or African American
    0 0 0 0 0
        Unknown or Other
    0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 3 1 4
        Not Hispanic or Latino
    3 7 0 5 15
        Unknown
    0 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Cohort 3: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RSV1 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RV521 3.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RV521 5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4: RV521 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 5: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 5: RV521 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received BID of RV521 2.5 mg/kg separated by 12 hours orally for 5 days. Subjects from Cohort 4 and 5 were included.

    Subject analysis set title
    Cohort 4 and 5 combined: Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received BID of placebo separated by 12 hours orally for 5 days. Subjects from Cohorts 4 and 5 were included.

    Subject analysis sets values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg Cohort 4 and 5 combined: RV521 2.5 mg/kg Cohort 4 and 5 combined: Placebo
    Number of subjects
    3
    3
    4
    3
    1
    4
    5
    8
    12
    6
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    3
    3
    2
    1
    1
    4
    5
    8
    12
    6
        Children (2-11 years)
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    Age Continuous
    99999 indicates standard deviation could not be calculated as a single subject was analysed.
    Units: months
        arithmetic mean (standard deviation)
    17.5 ± 4.00
    8.9 ± 4.51
    18.5 ± 13.54
    22.2 ± 7.97
    1.6 ± 99999
    1.2 ± 0.43
    2.0 ± 0.47
    3.0 ± 1.10
    2.4 ± 1.26
    1.9 ± 0.45
    Gender Categorical
    Units: Subjects
        Female
    1
    1
    3
    2
    0
    0
    0
    5
    5
    0
        Male
    2
    2
    1
    1
    1
    4
    5
    3
    7
    6
    Race
    Units: Subjects
        American Indian or Alaskan Native
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
        Asian
    1
    3
    1
    1
    0
    0
    1
    1
    1
    1
        White
    1
    0
    3
    1
    1
    4
    2
    6
    10
    3
        Black or African American
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
        Unknown or Other
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1
    0
    0
    0
    0
    1
    2
    1
    2
    2
        Not Hispanic or Latino
    2
    3
    4
    3
    1
    3
    2
    7
    10
    3
        Unknown
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: RV521 1.0 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1.

    Reporting group title
    Cohort 1: RV521 2.0 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1.

    Reporting group title
    Cohort 1: RV521 2.5 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1.

    Reporting group title
    Cohort 2: RV521 2.0 mg/kg
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1.
    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days.

    Reporting group title
    Cohort 3: RSV1 2.5 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 3: RV521 3.5 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 3: RV521 5 mg/kg
    Reporting group description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 4: RV521 2.5 mg/kg
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 5: Placebo
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Reporting group title
    Cohort 5: RV521 2.5 mg/kg
    Reporting group description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RSV1 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RV521 3.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 3: RV521 5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=6 months to <=36 months hospitalised with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4: RV521 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 5: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received placebo every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 5: RV521 2.5 mg/kg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days.

    Subject analysis set title
    Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received BID of RV521 2.5 mg/kg separated by 12 hours orally for 5 days. Subjects from Cohort 4 and 5 were included.

    Subject analysis set title
    Cohort 4 and 5 combined: Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Infants aged >=1 month to <6 months hospitalised with RSV LRTI received BID of placebo separated by 12 hours orally for 5 days. Subjects from Cohorts 4 and 5 were included.

    Primary: Part A: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Withdrawals due to TEAEs

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    End point title
    Part A: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Withdrawals due to TEAEs [1]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which did not necessarily have a causal relationship with the investigational medicinal product (IMP). TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalisation; resulted in persistent or significant disability/incapacity or other important medical event. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    From start of IMP on Day 1 up to Day 7
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
        TEAEs
    2
    5
    3
    1
        SAEs
    0
    1
    0
    0
        Withdrawals due to TEAEs
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Withdrawals due to TEAEs

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    End point title
    Part B: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Withdrawals due to TEAEs [2]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalisation; resulted in persistent or significant disability/incapacity or other important medical event. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    From start of IMP on Day 1 up to Day 12
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    1
    4
    5
    8
    Units: Subjects
        TEAEs
    1
    2
    1
    1
    1
    2
    3
    1
        SAEs
    0
    0
    0
    0
    0
    0
    0
    0
        Withdrawal due to TEAEs
    0
    0
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at Baseline [3]
    End point description
    Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic; cardiovascular; respiratory; gastrointestinal; and neurological examination. Clinical significance of results were determined by the investigator. Safety population included all subjects who received at least 1 dose of IMP. Here, 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
        General appearance; n=3,7,3,5
    0
    1
    0
    0
        HEENT; n=3,7,3,4
    1
    2
    0
    0
        Dermatologic; n=3,7,3,4
    0
    0
    0
    0
        Cardiovascular; n=3,7,3,5
    0
    1
    0
    0
        Respiratory; n=3,7,3,5
    3
    6
    2
    1
        Gastrointestinal; n=3,7,3,5
    0
    0
    0
    0
        Neurological; n=3,7,3,5
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose [4]
    End point description
    Physical examination included general appearance; HEENT; dermatologic; cardiovascular; respiratory; gastrointestinal; and neurological examination. Clinical significance of results were determined by the investigator. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Anytime between 18 to 24 hours post-dose on Day 1
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
        General appearance; n=3,6,2,6
    0
    0
    0
    0
        HEENT; n=3,6,1,5
    1
    2
    0
    0
        Dermatologic; n=3,6,1,5
    0
    0
    0
    0
        Cardiovascular; n=3,6,2,6
    0
    0
    0
    0
        Respiratory; n=3,6,2,6
    1
    4
    1
    1
        Gastrointestinal; n=3,6,2,6
    0
    0
    0
    0
        Neurological; n=3,6,2,6
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose [5]
    End point description
    Physical examination included general appearance; HEENT; dermatologic; cardiovascular; respiratory; gastrointestinal; and neurological examination. Clinical significance of results were determined by the investigator. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    At 48 hours post-dose on Day 1
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
        General appearance; n=3,6,2,6
    0
    0
    0
    0
        HEENT; n=3,6,2,5
    1
    1
    1
    0
        Dermatologic; n=3,6,2,5
    0
    0
    0
    0
        Cardiovascular; n=3,6,2,6
    0
    0
    0
    0
        Respiratory; n=3,6,2,6
    1
    3
    1
    1
        Gastrointestinal; n=3,6,2,6
    0
    0
    0
    0
        Neurological; n=3,6,2,6
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Physical Examination Results at Baseline [6]
    End point description
    Physical examination included general appearance; dermatologic; cardiovascular; respiratory; gastrointestinal; and neurological examination. Clinical significance of results were determined by the investigator. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    2
    3
    4
    3
    1
    4
    5
    7
    Units: Subjects
        General Appearance; n=2,3,4,3,1,4,5,7
    0
    0
    1
    0
    0
    0
    0
    1
        HEENT; n=2,3,3,3,1,4,5,7
    0
    0
    1
    1
    0
    0
    0
    0
        Dermatologic; n=2,3,4,3,1,4,5,7
    0
    0
    0
    0
    0
    0
    0
    0
        Cardiovascular; n=2,3,4,3,1,4,5,7
    0
    0
    1
    0
    0
    0
    0
    0
        Respiratory; n=2,3,4,3,1,4,5,7
    1
    2
    3
    3
    1
    2
    4
    3
        Gastrointestinal; n=2,3,4,3,1,4,5,7
    0
    0
    0
    0
    0
    0
    0
    0
        Neurological; n=2,3,4,3,1,4,5,7
    0
    0
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 [7]
    End point description
    Physical examination included general appearance; HEENT; dermatologic; cardiovascular; respiratory; gastrointestinal; and neurological examination. Clinical significance of results were determined by the investigator. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    0 [8]
    4
    5
    8
    Units: Subjects
        General appearance; n=3,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        HEENT; n=3,3,3,2,0,4,5,8
    0
    0
    1
    0
    0
    0
    0
        Dermatologic; n=3,3,3,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Cardiovascular; n=3,3,3,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Respiratory; n=3,3,4,2,0,4,5,8
    0
    1
    0
    0
    1
    0
    0
        Gastrointestinal; n=3,3,3,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Neurological; n=3,3,3,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
    Notes
    [8] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Baseline [9]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
    0
    2
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose [10]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose on Day 1
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
    0
    1
    1
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at 12 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at 12 Hours Post-Dose [11]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    12 hours post-dose on Day 1
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    2
    6
    Units: Subjects
    0
    2
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 18 to 24 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 18 to 24 Hours Post-Dose [12]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 18 to 24 hours post-dose on Day 1
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
    0
    2
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at 48 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at 48 Hours Post-Dose [13]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    48 hours post-dose on Day 1
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Vital Signs per Investigator’s Interpretation at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Vital Signs per Investigator’s Interpretation at Baseline [14]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    1
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 1

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 [15]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose 1 (Day 1)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    1
    4
    5
    8
    Units: Subjects
    1
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation At Pre-dose 2

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation At Pre-dose 2 [16]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 2 (Day 1)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    1
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 3

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 3 [17]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 3 (Day 2)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 4

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 4 [18]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 4 (Day 2)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    1
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 5

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 5 [19]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 5 (Day 3)
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    1
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 6

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 6 [20]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 6 (Day 3)
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    3
    4
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 6

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 [21]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose 6 (Day 3)
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    4
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 7

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 7 [22]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 7 (Day 4)
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    3
    5
    8
    Units: Subjects
    0
    1
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 8

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 8 [23]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 8 (Day 4)
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    2
    2
    2
    1
    3
    4
    6
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 9

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 9 [24]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 9 (Day 5)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    2
    2
    1
    1
    3
    4
    5
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation at Pre-dose 10 [25]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 10 (Day 5)
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    2
    1
    1
    1
    3
    4
    4
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 40 to 48 Hours Post-Dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Vital Signs per Investigator’s Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 [26]
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of subjects with abnormal clinically significant vital signs per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    0 [27]
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    Notes
    [27] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Hematology Results at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Hematology Results at Baseline [28]
    End point description
    Haematology parameters included basophils, eosinophils, lymphocytes, monocytes, neutrophils, haemoglobin (Hb), haematocrit (HCT), white blood cell count (WBC), red blood cell count (RBC), platelet count, mean cell volume (MCV), mean cell haemoglobin (MCH), and MCH concentration (MCHC). Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    2
    7
    3
    6
    Units: Subjects
        Basophils; below normal range; n=2,7,1,6
    0
    0
    0
    0
        Basophils; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Eosinophils; below normal range; n=2,7,1,6
    0
    0
    0
    0
        Eosinophils; above normal range; n=2,7,1,6
    0
    0
    0
    0
        MCHC; below normal range; n=2,7,1,6
    0
    0
    0
    0
        MCHC; above normal range; n=2,7,1,6
    0
    0
    0
    0
        MCH; below normal range; n=2,7,1,6
    0
    0
    0
    0
        MCH; above normal range; n=2,7,1,6
    0
    0
    0
    0
        MCV; below normal range; n=2,7,1,6
    0
    0
    0
    0
        MCV; above normal range; n=2,7,1,6
    0
    0
    0
    0
        RBC; below normal range; n=2,7,1,6
    0
    0
    0
    0
        RBC; above normal range; n=2,7,1,6
    0
    0
    0
    0
        HCT; below normal range; n=2,7,1,6
    0
    0
    0
    0
        HCT; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Hb; below normal range; n=2,7,3,6
    0
    0
    1
    0
        Hb; above normal range; n=2,7,3,6
    0
    0
    0
    0
        WBC; below normal range; n=2,7,1,6
    0
    0
    1
    1
        WBC; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Lymphocytes; below normal range; n=2,7,1,6
    0
    0
    0
    0
        Lymphocytes; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Monocytes; below normal range; n=2,7,1,6
    0
    0
    0
    0
        Monocytes; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Neutrophils; below normal range; n=2,7,1,6
    0
    0
    0
    0
        Neutrophils; above normal range; n=2,7,1,6
    0
    0
    0
    0
        Platelets; below normal range; n=2,7,1,6
    0
    2
    0
    1
        Platelets; above normal range; n=2,7,1,6
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Hematology Results at 48 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Hematology Results at 48 Hours Post-Dose [29]
    End point description
    Haematology parameters included basophils, eosinophils, lymphocytes, monocytes, neutrophils, Hb, HCT, WBC, RBC, platelet count, MCV, MCH and MCHC. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    48 hours post-dose on Day 1
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    5
    Units: Subjects
        Basophils; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Basophils; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Eosinophils; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Eosinophils; above normal range; n=3,6,1,5
    0
    0
    0
    0
        MCHC; below normal range; n=3,6,1,5
    0
    0
    0
    0
        MCHC; above normal range; n=3,6,1,5
    0
    0
    0
    0
        MCH; below normal range; n=3,6,1,5
    0
    0
    0
    0
        MCH; above normal range; n=3,6,1,5
    0
    0
    0
    0
        MCV; below normal range; n=3,6,1,5
    0
    0
    0
    0
        MCV; above normal range; n=3,6,1,5
    0
    0
    0
    0
        RBC; below normal range; n=3,6,1,5
    0
    0
    0
    0
        RBC; above normal range; n=3,6,1,5
    0
    0
    0
    0
        HCT; below normal range; n=3,6,1,5
    0
    0
    0
    0
        HCT; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Hb; below normal range; n=3,6,2,5
    0
    0
    0
    0
        Hb; above normal range; n=3,6,2,5
    0
    0
    0
    0
        WBC; below normal range; n=3,6,1,5
    0
    0
    0
    0
        WBC; above normal range; n=3,6,1,5
    0
    0
    0
    1
        Lymphocytes; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Lymphocytes; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Monocytes; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Monocytes; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Neutrophils; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Neutrophils; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Platelets; below normal range; n=3,6,1,5
    0
    1
    0
    0
        Platelets; above normal range; n=3,6,1,5
    1
    1
    1
    1
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Hematology Results at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Hematology Results at Baseline [30]
    End point description
    Haematology parameters included basophils, eosinophils, lymphocytes, monocytes, neutrophils, Hb, HCT, WBC, RBC, platelet count, MCV, MCH and MCHC. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    3
    1
    0 [31]
    4
    2
    7
    Units: Subjects
        Basophils; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Basophils; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Eosinophils; below normal range; n=3,3,3,1,0,4,2,7
    1
    0
    1
    0
    0
    0
    2
        Eosinophils; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        MCHC; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    1
        MCHC; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        MCH; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    1
        MCH; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        MCV; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    1
    0
    0
    0
    0
        MCV; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        RBC; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        RBC; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        HCT; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    1
    0
    2
    0
        HCT; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Hb; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    1
    0
    0
    1
    1
        Hb; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        WBC; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    2
    1
    0
        WBC; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    1
    0
        Lymphocytes; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Monocytes; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    1
        Monocytes; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    1
    1
        Neutrophils; below normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Neutrophils; above normal range; n=3,3,3,1,0,4,2,7
    0
    0
    0
    0
    0
    0
    0
        Platelets; below normal range; n=3,3,3,1,0,3,2,7
    1
    0
    1
    0
    0
    0
    0
        Platelets; above normal range; n=3,3,3,1,0,3,2,7
    1
    0
    0
    0
    0
    0
    1
    Notes
    [31] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 [32]
    End point description
    Haematology parameters included basophils, eosinophils, lymphocytes, monocytes, neutrophils, Hb, HCT, WBC, RBC, platelet count, MCV, MCH and MCHC. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    2
    4
    2
    0 [33]
    1
    3
    7
    Units: Subjects
        Basophils; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        Basophils; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        Eosinophils; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        Eosinophils; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        MCHC; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    1
        MCHC; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    1
    0
    0
    0
        MCH; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    1
    0
    0
    1
        MCH; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        MCV; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    1
    0
    0
    0
        MCV; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    0
        RBC; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        RBC; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        HCT; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    2
    0
        HCT; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    0
        Hb; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    1
        Hb; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    1
    0
        WBC; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    1
    1
        WBC; above normal range; n=3,2,4,2,0,1,3,7
    1
    0
    0
    0
    0
    0
    0
        Lymphocytes; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    1
        Lymphocytes; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        Monocytes; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    1
        Monocytes; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    1
        Neutrophils; below normal range; n=3,2,4,2,0,1,3,7
    0
    0
    0
    0
    0
    1
    1
        Neutrophils; above normal range; n=3,2,4,2,0,1,3,7
    0
    0
    1
    0
    0
    1
    0
        Platelets; below normal range; n=3,2,3,1,0,1,3,7
    0
    0
    0
    0
    0
    0
    0
        Platelets; above normal range; n=3,2,3,1,0,1,3,7
    2
    1
    2
    0
    0
    2
    6
    Notes
    [33] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinical Chemistry Results at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Clinical Chemistry Results at Baseline [34]
    End point description
    Clinical chemistry parameters included creatinine, urea (or blood urea nitrogen), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), total bilirubin, albumin, total protein, sodium, potassium, chloride, glucose, and calcium. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
        ALT; below normal range; n=3,7,3,5
    0
    0
    0
    0
        ALT; above normal range; n=3,7,3,5
    0
    0
    0
    0
        Albumin; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Albumin; above normal range; n=3,7,3,6
    0
    0
    0
    0
        ALP; below normal range; n=3,7,3,5
    0
    0
    0
    0
        ALP; above normal range; n=3,7,3,5
    0
    0
    0
    0
        AST; below normal range; n=3,7,3,5
    0
    0
    0
    0
        AST; above normal range; n=3,7,3,5
    0
    0
    0
    0
        Bilirubin; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Bilirubin; above normal range; n=3,7,3,6
    0
    0
    0
    0
        Calcium; below normal range; n=3,7,3,6
    0
    1
    0
    0
        Calcium; above normal range; n=3,7,3,6
    0
    0
    0
    1
        Chloride; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Chloride; above normal range; n=3,7,3,6
    0
    0
    0
    0
        Creatinine; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Creatinine; above normal range; n=3,7,3,6
    0
    0
    0
    0
        GGT; below normal range; n=3,7,3,5
    0
    0
    0
    0
        GGT; above normal range; n=3,7,3,5
    0
    0
    0
    0
        Glucose; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Glucose; above normal range; n=3,7,3,6
    0
    0
    0
    0
        LDH; below normal range; n=3,7,3,3
    0
    0
    0
    0
        LDH; above normal range; n=3,7,3,3
    0
    0
    0
    0
        Potassium; below normal range; n=3,7,3,4
    0
    0
    0
    0
        Potassium; above normal range; n=3,7,3,4
    0
    0
    0
    1
        Protein; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Protein; above normal range; n=3,7,3,6
    0
    0
    0
    0
        Sodium; below normal range; n=3,7,3,6
    0
    1
    0
    0
        Sodium; above normal range; n=3,7,3,6
    0
    0
    0
    0
        Urea; below normal range; n=3,7,3,6
    0
    0
    0
    0
        Urea; above normal range; n=3,7,3,6
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose [35]
    End point description
    Clinical chemistry parameters included creatinine, urea, AST, ALT, GGT, ALP, LDH, total bilirubin, albumin, total protein, sodium, potassium, chloride, glucose, and calcium. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    48 hours post-dose on Day 1
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
        ALT; below normal range; n=3,6,1,5
    0
    0
    0
    0
        ALT; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Albumin; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Albumin; above normal range; n=3,6,1,5
    0
    0
    0
    0
        ALP; below normal range; n=3,6,1,5
    0
    0
    0
    0
        ALP; above normal range; n=3,6,1,5
    0
    0
    0
    0
        AST; below normal range; n=3,5,1,5
    0
    0
    0
    0
        AST; above normal range; n=3,5,1,5
    0
    0
    0
    0
        Bilirubin; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Bilirubin; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Calcium; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Calcium; above normal range; n=3,6,1,5
    0
    0
    0
    1
        Chloride; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Chloride; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Creatinine; below normal range; n=3,6,1,4
    0
    0
    0
    0
        Creatinine; above normal range; n=3,6,1,4
    0
    0
    0
    0
        GGT; below normal range; n=3,6,1,5
    0
    0
    0
    0
        GGT; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Glucose; below normal range; n=3,6,1,4
    0
    0
    0
    1
        Glucose; above normal range; n=3,6,1,4
    0
    0
    0
    0
        LDH; below normal range; n=3,5,1,5
    0
    0
    0
    0
        LDH; above normal range; n=3,5,1,5
    0
    0
    0
    0
        Potassium; below normal range; n=3,5,1,4
    0
    0
    0
    0
        Potassium; above normal range; n=3,5,1,4
    0
    1
    0
    3
        Protein; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Protein; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Sodium; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Sodium; above normal range; n=3,6,1,5
    0
    0
    0
    0
        Urea; below normal range; n=3,6,1,5
    0
    0
    0
    0
        Urea; above normal range; n=3,6,1,5
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinical Chemistry Results at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Clinical Chemistry Results at Baseline [36]
    End point description
    Clinical chemistry parameters included creatinine, urea, AST, ALT, GGT, ALP, LDH, total bilirubin, albumin, total protein, sodium, potassium, chloride, glucose, and calcium. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'n' signifies number of subjects evaluable for the specified categories. 99999 indicates data was not available as no subjects were evaluable.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    1
    4
    5
    8
    Units: Subjects
        ALT; below normal range; n=3,3,4,3,0,4,5,8
    0
    0
    0
    0
    99999
    0
    0
    0
        ALT; above normal range; n=3,3,4,3,0,4,5,8
    0
    0
    0
    0
    99999
    0
    0
    3
        Albumin; below normal range; n=2,3,3,3,1,4,4,8
    0
    0
    0
    1
    0
    0
    1
    0
        Albumin; above normal range; n=2,3,3,3,1,4,4,8
    0
    0
    0
    0
    0
    0
    0
    1
        ALP; below normal range; n=2,3,3,3,1,4,4,5
    0
    0
    0
    0
    0
    0
    0
    0
        ALP; above normal range; n=2,3,3,3,1,4,4,5
    0
    0
    0
    0
    0
    0
    0
    0
        AST; below normal range; n=3,3,4,3,0,4,5,7
    0
    0
    0
    0
    99999
    0
    0
    0
        AST; above normal range; n=3,3,4,3,0,4,5,7
    0
    0
    0
    0
    99999
    0
    0
    0
        Bilirubin; below normal range; n=3,3,4,3,1,4,4,8
    1
    0
    2
    1
    0
    0
    0
    2
        Bilirubin; above normal range; n=3,3,4,3,1,4,4,8
    0
    0
    0
    0
    0
    0
    0
    0
        Calcium; below normal range; n=2,3,2,3,1,4,3,6
    0
    0
    0
    0
    0
    0
    0
    1
        Calcium; above normal range; n=2,3,2,3,1,4,3,6
    0
    0
    0
    0
    0
    0
    0
    1
        Chloride; below normal range; n=3,3,4,3,1,4,5,8
    1
    0
    0
    0
    0
    0
    0
    0
        Chloride; above normal range; n=3,3,4,3,1,4,5,8
    0
    0
    0
    0
    0
    0
    0
    0
        Creatinine; below normal range; n=3,3,4,3,1,4,5,8
    1
    0
    2
    2
    0
    0
    1
    4
        Creatinine; above normal range; n=3,3,4,3,1,4,5,8
    0
    0
    0
    0
    0
    0
    0
    0
        GGT; below normal range; n=2,3,4,3,1,4,4,8
    0
    0
    0
    0
    0
    0
    0
    0
        GGT; above normal range; n=2,3,4,3,1,4,4,8
    0
    0
    0
    0
    0
    0
    0
    0
        Glucose; below normal range; n=3,3,4,3,1,4,4,8
    0
    0
    0
    0
    0
    0
    0
    0
        Glucose; above normal range; n=3,3,4,3,1,4,4,8
    1
    0
    3
    0
    0
    1
    0
    4
        LDH; below normal range; n=0,3,2,3,0,2,2,3
    99999
    0
    0
    0
    99999
    0
    0
    0
        LDH; above normal range; n=0,3,2,3,0,2,2,3
    99999
    0
    0
    1
    99999
    0
    0
    0
        Potassium; below normal range; n=1,3,3,3,0,3,5,7
    0
    0
    0
    0
    99999
    0
    0
    0
        Potassium; above normal range; n=1,3,3,3,0,3,5,7
    0
    1
    0
    1
    99999
    0
    1
    2
        Protein; below normal range; n=3,3,4,3,1,4,4,7
    0
    0
    0
    0
    0
    0
    1
    2
        Protein; above normal range; n=3,3,4,3,1,4,4,7
    0
    0
    0
    0
    0
    0
    0
    1
        Sodium; below normal range; n=3,3,4,3,1,4,5,8
    1
    0
    0
    0
    0
    0
    0
    1
        Sodium; above normal range; n=3,3,4,3,1,4,5,8
    0
    0
    0
    1
    0
    0
    0
    0
        Urea; below normal range; n=2,3,4,2,1,4,5,8
    0
    0
    1
    0
    0
    0
    0
    3
        Urea; above normal range; n=2,3,4,2,1,4,5,8
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 [37]
    End point description
    Clinical chemistry parameters included creatinine, urea, AST, ALT, GGT, ALP, LDH, total bilirubin, albumin, total protein, sodium, potassium, chloride, glucose, and calcium. Institutional laboratory normal ranges were used. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    0 [38]
    4
    5
    8
    Units: Subjects
        ALT; below normal range; n=3,3,3,2,0,3,5,6
    0
    0
    0
    0
    0
    0
    0
        ALT; above normal range; n=3,3,3,2,0,3,5,6
    0
    0
    0
    0
    0
    0
    1
        Albumin; below normal range; n=3,3,4,2,0,4,4,6
    0
    0
    0
    0
    0
    0
    1
        Albumin; above normal range; n=3,3,4,2,0,4,4,6
    0
    0
    0
    0
    0
    0
    1
        ALP; below normal range; n=3,3,3,2,0,4,4,7
    0
    0
    0
    0
    0
    0
    0
        ALP; above normal range; n=3,3,3,2,0,4,4,7
    0
    0
    1
    0
    0
    0
    0
        AST; below normal range; n=3,3,2,2,0,2,4,7
    0
    0
    0
    0
    0
    0
    0
        AST; above normal range; n=3,3,2,2,0,2,4,7
    0
    0
    0
    0
    0
    0
    0
        Bilirubin; below normal range; n=3,3,4,2,0,4,4,6
    1
    0
    1
    0
    0
    0
    1
        Bilirubin; above normal range; n=3,3,4,2,0,4,4,6
    0
    0
    0
    0
    0
    0
    0
        Calcium; below normal range; n=3,3,3,2,0,4,4,7
    0
    0
    0
    0
    0
    0
    0
        Calcium; above normal range; n=3,3,3,2,0,4,4,7
    0
    1
    1
    0
    1
    0
    5
        Chloride; below normal range; n=3,3,4,2,0,4,5,8
    1
    0
    0
    0
    0
    0
    0
        Chloride; above normal range; n=3,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Creatinine; below normal range; n=2,3,4,2,0,4,5,8
    1
    0
    0
    1
    0
    1
    4
        Creatinine; above normal range; n=2,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        GGT; below normal range; n=3,3,4,2,0,4,4,7
    0
    0
    0
    0
    0
    0
    0
        GGT; above normal range; n=3,3,4,2,0,4,4,7
    0
    0
    0
    1
    0
    1
    0
        Glucose; below normal range; n=2,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Glucose; above normal range; n=2,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    1
    1
        LDH; below normal range; n=2,3,2,1,0,2,3,6
    0
    0
    0
    0
    0
    0
    0
        LDH; above normal range; n=2,3,2,1,0,2,3,6
    0
    0
    0
    0
    0
    0
    1
        Potassium; below normal range; n=2,3,2,2,0,2,4,6
    0
    0
    0
    0
    0
    0
    0
        Potassium; above normal range; n=2,3,2,2,0,2,4,6
    0
    1
    0
    1
    0
    1
    1
        Protein; below normal range; n=3,3,4,2,0,4,4,7
    0
    0
    0
    0
    0
    1
    1
        Protein; above normal range; n=3,3,4,2,0,4,4,7
    0
    0
    0
    0
    0
    0
    0
        Sodium; below normal range; n=3,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
        Sodium; above normal range; n=3,3,4,2,0,4,5,8
    0
    0
    0
    1
    0
    0
    0
        Urea; below normal range; n=3,3,4,2,0,4,5,8
    1
    0
    1
    1
    0
    1
    0
        Urea; above normal range; n=3,3,4,2,0,4,5,8
    0
    0
    0
    0
    0
    0
    0
    Notes
    [38] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Urinalysis Results at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Urinalysis Results at Baseline [39]
    End point description
    Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per high power field [hpf]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field [lpf]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    2
    7
    3
    6
    Units: Subjects
        Epithelial Cells; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Epithelial Cells; above normal range; n=2,7,3,6
    0
    0
    0
    0
        Erythrocytes; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Erythrocytes; above normal range; n=2,7,3,6
    0
    0
    0
    0
        Granular casts; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Granular casts; above normal range; n=2,7,3,6
    0
    0
    0
    0
        Hyaline casts; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Hyaline casts; above normal range; n=2,7,3,6
    0
    0
    0
    0
        Leukocytes; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Leukocytes; above normal range; n=2,7,3,6
    0
    0
    0
    0
        RBC cast; below normal range; n=2,7,3,6
    0
    0
    0
    0
        RBC cast; above normal range; n=2,7,3,6
    0
    0
    0
    0
        WBC cast; below normal range; n=2,7,3,6
    0
    0
    0
    0
        WBC cast; above normal range; n=2,7,3,6
    0
    0
    0
    0
        Waxy cast; below normal range; n=2,7,3,6
    0
    0
    0
    0
        Waxy cast; above normal range; n=2,7,3,6
    0
    0
    0
    0
        pH; below normal range; n=2,7,3,4
    0
    0
    0
    0
        pH; above normal range; n=2,7,3,4
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Urinalysis Results at 48 Hours Post-dose

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    End point title
    Part A: Number of Subjects With Abnormal Urinalysis Results at 48 Hours Post-dose [40]
    End point description
    Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    48 hours post-dose on Day 1
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    0 [41]
    6
    Units: Subjects
        Epithelial Cells; below normal range; n=3,6,0,6
    0
    0
    0
        Epithelial Cells; above normal range; n= 3,6,0,6
    0
    0
    0
        Erythrocytes; below normal range; n=3,6,0,6
    0
    0
    0
        Erythrocytes; above normal range; n=3,6,0,6
    1
    0
    1
        Granular casts; below normal range; n=3,6,0,6
    0
    0
    0
        Granular casts; above normal range; n=3,6,0,6
    0
    0
    0
        Hyaline casts; below normal range; n=3,6,0,6
    0
    0
    0
        Hyaline casts; above normal range; n=3,6,0,6
    0
    0
    0
        Leukocytes; below normal range; n=3,6,0,6
    0
    0
    0
        Leukocytes; above normal range; n=3,6,0,6
    0
    0
    0
        RBC cast; below normal range; n=3,6,0,6
    0
    0
    0
        RBC cast; above normal range; n=3,6,0,6
    0
    0
    0
        WBC cast; below normal range; n=3,6,0,6
    0
    0
    0
        WBC cast; above normal range; n=3,6,0,6
    0
    0
    0
        Waxy cast; below normal range; n=3,6,0,6
    0
    0
    0
        Waxy cast; above normal range; n=3,6,0,6
    0
    0
    0
        pH; below normal range; n=2,6,0,5
    0
    0
    0
        pH; above normal range; n=2,6,0,5
    0
    2
    1
    Notes
    [41] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Urinalysis Results at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Urinalysis Results at Baseline [42]
    End point description
    Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and ‘n’ signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    2
    3
    2
    2
    1
    2
    4
    5
    Units: Subjects
        Epi Cells; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Epi Cells; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Ery; below normal range; n=2,3,2,2,1,2,4,3
    0
    0
    0
    0
    0
    0
    0
    1
        Ery; above normal range; n=2,3,2,2,1,2,4,3
    0
    1
    1
    0
    0
    0
    0
    0
        Gran casts; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Gran casts; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Hya casts; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Hya casts; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Leuko; below normal range; n=2,3,2,2,1,2,4,3
    0
    0
    0
    0
    0
    0
    0
    1
        Leuko; above normal range; n=2,3,2,2,1,2,4,3
    0
    0
    0
    0
    0
    1
    2
    1
        RBC cast; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        RBC cast; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        WBC cast; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        WBC cast; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Waxy cast; below normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        Waxy cast; above normal range; n=2,3,1,2,1,2,2,2
    0
    0
    0
    0
    0
    0
    0
    0
        pH; below normal range; n=3,3,2,3,1,2,4,5
    0
    0
    0
    0
    0
    0
    0
    0
        pH; above normal range; n=3,3,2,3,1,2,4,5
    0
    0
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 [43]
    End point description
    Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and ‘n’ signifies number of subjects evaluable for the specified categories.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    2
    3
    2
    1
    0 [44]
    0 [45]
    3
    5
    Units: Subjects
        Epi Cells; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Epi Cells; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Ery; below normal range; n=2,3,2,1,0,0,3,2
    0
    0
    0
    0
    0
    0
        Ery; above normal range; n=2,3,2,1,0,0,3,2
    0
    0
    1
    0
    2
    0
        Gran casts; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Gran casts; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Hya casts; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Hya casts; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Leuko; below normal range; n=2,3,2,1,0,0,3,2
    0
    0
    0
    0
    0
    0
        Leuko; above normal range; n=2,3,2,1,0,0,3,2
    0
    0
    0
    0
    1
    0
        RBC cast; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        RBC cast; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        WBC cast; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        WBC cast; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Waxy cast; below normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        Waxy cast; above normal range; n=2,3,1,1,0,0,1,2
    0
    0
    0
    0
    0
    0
        pH; below normal range; n=2,3,2,1,0,0,3,5
    0
    0
    0
    0
    0
    0
        pH; above normal range; n=2,3,2,1,0,0,3,5
    1
    0
    1
    1
    0
    2
    Notes
    [44] - No subjects were evaluable
    [45] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Baseline

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Baseline [46]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose [47]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose on Day 1
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 18 to 24 Hours Post-dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 18 to 24 Hours Post-dose [48]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 18 to 24 hours post-dose on Day 1
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Baseline

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Baseline [49]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP.
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose on Day 1)
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    3
    1
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at 48 Hours Post-dose

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    End point title
    Part A: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at 48 Hours Post-dose [50]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    48 hours post-dose on Day 1
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned.
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    6
    2
    6
    Units: Subjects
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 1

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 [51]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose 1 on Day 1
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    3
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 3

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 3 [52]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 3 (Day 2)
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 5

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 5 [53]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 5 (Day 3)
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 6

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 [54]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 4 to 5 hours post-dose 6 (Day 3)
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    3
    2
    1
    4
    4
    7
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 10 [55]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose (Day 5)
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    2
    1
    0 [56]
    0 [57]
    3
    3
    4
    Units: Subjects
    0
    0
    0
    0
    0
    0
    Notes
    [56] - No subjects were evaluable
    [57] - No subjects were evaluable
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 8

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation at Pre-dose 8 [58]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre-dose 8 (Day 4)
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    2
    2
    2
    1
    1
    4
    5
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 40 to 48 Hours Post-Dose 10

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    End point title
    Part B: Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Results per Investigator’s Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 [59]
    End point description
    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of subjects with abnormal clinically significant results for any ECG parameter per investigators interpretation are reported in this outcome measure. Safety population included all subjects who received at least 1 dose of IMP. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Anytime between 40 to 48 hours post-dose 10 on Day 5
    Notes
    [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is specific to Part B; hence, only arms for Part B are included.
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    0 [60]
    4
    5
    8
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    Notes
    [60] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part A: Time to Maximum Plasma Concentration (tmax)

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    End point title
    Part A: Time to Maximum Plasma Concentration (tmax)
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement.
    End point type
    Secondary
    End point timeframe
    Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Hours
        median (full range (min-max))
    4.17 (4 to 4.5)
    4.58 (4.42 to 6.18)
    7 (4.87 to 48.3)
    4.78 (2 to 6.67)
    No statistical analyses for this end point

    Secondary: Part B: Time to Maximum Plasma Concentration (tmax)

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    End point title
    Part B: Time to Maximum Plasma Concentration (tmax)
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    4
    3
    4
    8
    Units: Hours
    median (full range (min-max))
        Dose 1; n=3,4,3,4,8
    4.6 (4.33 to 4.63)
    4.32 (3.58 to 11.6)
    4.17 (2.5 to 4.17)
    4.03 (3.77 to 5.5)
    4.31 (4.08 to 12)
        Dose 6; n=3,3,2,3,8
    4.43 (4.38 to 4.5)
    3.95 (3.67 to 4.88)
    4.53 (4.05 to 5)
    4.58 (3.58 to 11.5)
    4.29 (0 to 11.8)
    No statistical analyses for this end point

    Secondary: Part A: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    Part A: Maximum Observed Plasma Concentration (Cmax)
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement.
    End point type
    Secondary
    End point timeframe
    Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    3
    6
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    1.59 ± 2.76
    8.08 ± 7.94
    2.98 ± 3.09
    28 ± 17.5
    No statistical analyses for this end point

    Secondary: Part B: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    Part B: Maximum Observed Plasma Concentration (Cmax)
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'n' signifies number of subjects evaluable for the specified categories.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    4
    3
    4
    8
    Units: Nanogram per milliliter
    arithmetic mean (standard deviation)
        Dose 1; n=3,4,3,4,8
    43.2 ± 36.7
    24.9 ± 20
    115 ± 182
    39.3 ± 26.4
    56.5 ± 88.1
        Dose 6; n=3,3,2,3,8
    30.9 ± 31.3
    67.8 ± 86.3
    212 ± 157
    133 ± 64.8
    177 ± 151
    No statistical analyses for this end point

    Secondary: Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

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    End point title
    Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
    End point description
    AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at 0 hour. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    0 hour, anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    3
    7
    2
    6
    Units: Hours*nanogram per milliliter
        arithmetic mean (standard deviation)
    9.22 ± 16
    45 ± 48
    6.46 ± 9.14
    201 ± 143
    No statistical analyses for this end point

    Secondary: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

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    End point title
    Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
    End point description
    AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at 0 hour on Day 1. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint and 'n' signifies number of subjects evaluable for the specified categories. 99999 indicates data could not be calculated due to insufficient number of subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (0 hour, anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    1
    2
    1
    4
    Units: Hours*nanogram per milliliter
    arithmetic mean (standard deviation)
        Dose 1; n=0,0,2,1,4
    99999 ± 99999
    99999 ± 99999
    1170 ± 1460
    127 ± 99999
    160 ± 120
        Dose 6; 1,1,0,1,1
    87.9 ± 99999
    184 ± 99999
    99999 ± 99999
    1110 ± 99999
    1600 ± 99999
    No statistical analyses for this end point

    Secondary: Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

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    End point title
    Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
    End point description
    Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at 0 hour. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint. 99999 signifies data could not be calculated due to insufficient subjects.
    End point type
    Secondary
    End point timeframe
    0 hour, anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    1
    6
    2
    6
    Units: Hours*nanogram per milliliter
        arithmetic mean (standard deviation)
    23.1 ± 99999
    48.1 ± 49.9
    14 ± 1.46
    287 ± 217
    No statistical analyses for this end point

    Secondary: Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

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    End point title
    Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
    End point description
    Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at 0 hour on Day 1. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (0 hour, anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    4
    2
    4
    8
    Units: Hours*nanogram per milliliter
    arithmetic mean (standard deviation)
        Dose 1; n=3,4,2,4,8
    288 ± 251
    163 ± 132
    1170 ± 1460
    342 ± 240
    315 ± 386
        Dose 6; n=3,3,2,3,8
    225 ± 233
    477 ± 594
    1560 ± 1010
    1310 ± 802
    1140 ± 845
    No statistical analyses for this end point

    Secondary: Part B: Terminal Half-life (t1/2)

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    End point title
    Part B: Terminal Half-life (t1/2)
    End point description
    T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    0 [65]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [61] - No subjects were evaluable
    [62] - No subjects were evaluable
    [63] - No subjects were evaluable
    [64] - No subjects were evaluable
    [65] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part A: Terminal Half-life (t1/2)

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    End point title
    Part A: Terminal Half-life (t1/2)
    End point description
    T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    0 [66]
    0 [67]
    0 [68]
    5
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    6.22 ± 1.46
    Notes
    [66] - No subjects were evaluable
    [67] - No subjects were evaluable
    [68] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to inf)

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    End point title
    Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to inf)
    End point description
    AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at 0 hour. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    0 hour, anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    0 [69]
    0 [70]
    0 [71]
    5
    Units: Hours*nanogram per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    231 ± 161
    Notes
    [69] - No subjects were evaluable
    [70] - No subjects were evaluable
    [71] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to inf)

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    End point title
    Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to inf)
    End point description
    AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at 0 hour on Day 1. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (0 hour, anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [72]
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    Units: Hours*nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [72] - No subjects were evaluable
    [73] - No subjects were evaluable
    [74] - No subjects were evaluable
    [75] - No subjects were evaluable
    [76] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part A: Trough Concentration at the end of First Dosing Interval (C12)

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    End point title
    Part A: Trough Concentration at the end of First Dosing Interval (C12)
    End point description
    PK Population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At 12 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    0 [77]
    0 [78]
    0 [79]
    0 [80]
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [77] - No subjects were evaluable
    [78] - No subjects were evaluable
    [79] - No subjects were evaluable
    [80] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Trough Concentration at the end of First Dosing Interval (C12)

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    End point title
    Part B: Trough Concentration at the end of First Dosing Interval (C12)
    End point description
    PK Population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At 12 hours post-dose 6
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    2
    3
    8
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    7.6 ± 8.33
    9.55 ± 9.75
    36.9 ± 5.3
    89.8 ± 99.1
    124 ± 167
    No statistical analyses for this end point

    Secondary: Part A: Predicted Plasma Clearance

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    End point title
    Part A: Predicted Plasma Clearance
    End point description
    Clearance was calculated as Dose divided by AUC(0 to inf). PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    0 [81]
    0 [82]
    0 [83]
    5
    Units: Liters per hour per kilogram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    12.7 ± 7.66
    Notes
    [81] - No subjects were evaluable
    [82] - No subjects were evaluable
    [83] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Predicted Plasma Clearance

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    End point title
    Part B: Predicted Plasma Clearance
    End point description
    Clearance was calculated as Dose divided by AUC(0 to inf). PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    0 [88]
    Units: Liters per hour per kilogram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [84] - No subjects were evaluable
    [85] - No subjects were evaluable
    [86] - No subjects were evaluable
    [87] - No subjects were evaluable
    [88] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration

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    End point title
    Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration
    End point description
    Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
    End point values
    Cohort 1: RV521 1.0 mg/kg Cohort 1: RV521 2.0 mg/kg Cohort 1: RV521 2.5 mg/kg Cohort 2: RV521 2.0 mg/kg
    Number of subjects analysed
    0 [89]
    0 [90]
    0 [91]
    5
    Units: Litres per kilogram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    119 ± 87.4
    Notes
    [89] - No subjects were evaluable
    [90] - No subjects were evaluable
    [91] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration

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    End point title
    Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration
    End point description
    Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [92]
    0 [93]
    0 [94]
    0 [95]
    0 [96]
    Units: Liters per kilogram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [92] - No subjects were evaluable
    [93] - No subjects were evaluable
    [94] - No subjects were evaluable
    [95] - No subjects were evaluable
    [96] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Accumulation Ratio

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    End point title
    Part B: Accumulation Ratio
    End point description
    Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [97]
    0 [98]
    0 [99]
    0 [100]
    0 [101]
    Units: Ratio
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [97] - No subjects were evaluable
    [98] - No subjects were evaluable
    [99] - No subjects were evaluable
    [100] - No subjects were evaluable
    [101] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Percentage Fluctuation

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    End point title
    Part B: Percentage Fluctuation
    End point description
    Percentage fluctuation was calculated as 100*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint. 99999 indicates data could not be calculated due to insufficient number of subjects.
    End point type
    Secondary
    End point timeframe
    Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    1
    0 [102]
    1
    1
    Units: Percentage of fluctuation
        arithmetic mean (standard deviation)
    132 ± 99999
    123 ± 99999
    ±
    8.63 ± 99999
    98.1 ± 99999
    Notes
    [102] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the end of Last Dosing Interval (AUC0-tau)

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    End point title
    Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the end of Last Dosing Interval (AUC0-tau)
    End point description
    AUC(0 to tau) was determined using the linear trapezoidal method. No sampling was done at 0 hour. PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint. 99999 indicates data could not be calculated due to insufficient number of subjects.
    End point type
    Secondary
    End point timeframe
    Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    1
    0 [103]
    1
    1
    Units: Hours*nanogram per milliliter
        arithmetic mean (standard deviation)
    87.9 ± 99999
    184 ± 99999
    ±
    1110 ± 99999
    1600 ± 99999
    Notes
    [103] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Average Plasma Concentration Over Dosing Interval (Cavg)

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    End point title
    Part B: Average Plasma Concentration Over Dosing Interval (Cavg)
    End point description
    Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours). PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint. 99999 indicates data could not be calculated due to insufficient number of subjects.
    End point type
    Secondary
    End point timeframe
    Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    1
    1
    0 [104]
    1
    1
    Units: Nanogram per milliliter
        arithmetic mean (standard deviation)
    7.32 ± 99999
    15.3 ± 99999
    ±
    92.7 ± 99999
    133 ± 99999
    Notes
    [104] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Minimum Observed Plasma Concentration

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    End point title
    Part B: Minimum Observed Plasma Concentration
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [105]
    0 [106]
    0 [107]
    0 [108]
    0 [109]
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [105] - No subjects were evaluable
    [106] - No subjects were evaluable
    [107] - No subjects were evaluable
    [108] - No subjects were evaluable
    [109] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Plasma Trough Concentration

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    End point title
    Part B: Plasma Trough Concentration
    End point description
    PK population included all subjects who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
    End point values
    Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: RV521 2.5 mg/kg Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    0 [110]
    0 [111]
    0 [112]
    0 [113]
    0 [114]
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    Notes
    [110] - No subjects were evaluable
    [111] - No subjects were evaluable
    [112] - No subjects were evaluable
    [113] - No subjects were evaluable
    [114] - No subjects were evaluable
    No statistical analyses for this end point

    Secondary: Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)

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    End point title
    Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
    End point description
    Percent change from baseline in log10 total RSV viral load was analysed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the subjects treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan. Modified Intent to Treat (mITT) population included all subjects who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'n' signifies subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
    End point values
    Cohort 4 and 5 combined: RV521 2.5 mg/kg Cohort 4 and 5 combined: Placebo
    Number of subjects analysed
    12
    6
    Units: Percent change
    least squares mean (standard error)
        60 hours; n=5,11
    -31.29 ± 8.19
    -23.27 ± 10.48
        156 hours; n=4,12
    -47.53 ± 8.03
    -32.31 ± 11.52
    Statistical analysis title
    Placebo versus RV521 2.5 mg/kg
    Statistical analysis description
    Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for subject and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.
    Comparison groups
    Cohort 4 and 5 combined: Placebo v Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [115]
    Method
    Parameter type
    Mean difference (net)
    Point estimate
    -15.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -40.15
         upper limit
    9.7
    Notes
    [115] - 156 hours
    Statistical analysis title
    Placebo versus RV521 2.5 mg/kg
    Statistical analysis description
    Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for subject and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.
    Comparison groups
    Cohort 4 and 5 combined: Placebo v Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [116]
    Method
    Parameter type
    Mean difference (net)
    Point estimate
    -8.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.78
         upper limit
    15.74
    Notes
    [116] - 60 hours

    Secondary: Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)

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    End point title
    Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)
    End point description
    Percent change from baseline in log10 total RSV viral load was analysed using a mixed effects ANCOVA model. The model was fitted to the subjects treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan. mITT population included all subjects who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'n' signifies subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
    End point values
    Cohort 4 and 5 combined: RV521 2.5 mg/kg Cohort 4 and 5 combined: Placebo
    Number of subjects analysed
    12
    6
    Units: Percent change
    least squares mean (standard error)
        60 hours; 5, 11
    -54.74 ± 34.87
    -69.56 ± 46.32
        156 hours; 4, 12
    -41.20 ± 34.01
    -10.00 ± 51.88
    Statistical analysis title
    Placebo versus RV521 2.5 mg/kg
    Statistical analysis description
    Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for subject and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.
    Comparison groups
    Cohort 4 and 5 combined: Placebo v Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [117]
    Method
    Parameter type
    Mean difference (net)
    Point estimate
    -31.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -143.96
         upper limit
    81.57
    Notes
    [117] - 156 hours
    Statistical analysis title
    Placebo versus RV521 2.5 mg/kg
    Statistical analysis description
    Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for subject and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.
    Comparison groups
    Cohort 4 and 5 combined: Placebo v Cohort 4 and 5 combined: RV521 2.5 mg/kg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [118]
    Method
    Parameter type
    Mean difference (net)
    Point estimate
    14.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -91.68
         upper limit
    121.33
    Notes
    [118] - 60 hours

    Secondary: Part B: Time to Resolution of RSV-Related Signs and Symptoms

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    End point title
    Part B: Time to Resolution of RSV-Related Signs and Symptoms
    End point description
    Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomisation to the time that RSV-related signs and symptoms were absent. mITT population included all subjects who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to 13 days
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Days
        median (full range (min-max))
    6.20 (6.1 to 6.6)
    6.20 (6.2 to 6.3)
    6.45 (5.9 to 6.8)
    3.80 (2.6 to 5.0)
    4.90 (4.9 to 4.9)
    6.30 (4.6 to 6.9)
    6.00 (2.5 to 6.7)
    6.10 (4.1 to 6.9)
    No statistical analyses for this end point

    Secondary: Part B: Time to Improvement in RSV-Related Signs and Symptoms

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    End point title
    Part B: Time to Improvement in RSV-Related Signs and Symptoms
    End point description
    Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomisation to the time that RSV-related signs and symptoms were mild or absent. mITT population included all subjects who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to 13 days
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    2
    3
    4
    2
    1
    4
    5
    8
    Units: Days
        median (full range (min-max))
    2.25 (1.5 to 3.0)
    0.50 (0.5 to 6.3)
    3.15 (2.1 to 5.9)
    2.55 (1.1 to 4.0)
    1.90 (1.9 to 1.9)
    4.35 (3.6 to 6.9)
    3.00 (1.0 to 6.0)
    6.00 (1.5 to 6.9)
    No statistical analyses for this end point

    Secondary: Part B: RSV Clinical Scoring System Scores

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    End point title
    Part B: RSV Clinical Scoring System Scores
    End point description
    RSV clinical score was a composite score for infants with RSV infection >= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score <=5, moderate: score > 5 but < 9 and severe: score >=9. mITT population was analysed. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint and 'n' signifies subjects evaluable at the specified timepoints. 99999 signifies data could not be calculated due to insufficient subjects.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5
    End point values
    Cohort 3: Placebo Cohort 3: RSV1 2.5 mg/kg Cohort 3: RV521 3.5 mg/kg Cohort 3: RV521 5 mg/kg Cohort 4: Placebo Cohort 4: RV521 2.5 mg/kg Cohort 5: Placebo Cohort 5: RV521 2.5 mg/kg
    Number of subjects analysed
    3
    3
    4
    2
    1
    4
    5
    8
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline; n=2,3,4,2,1,4,5,8
    3.5 ± 2.12
    5.0 ± 1.73
    6.8 ± 2.50
    4.5 ± 6.36
    8.0 ± 99999
    6.8 ± 2.22
    6.2 ± 3.56
    6.0 ± 2.73
        pre-dose 3; n=3,3,4,2,1,4,5,8
    2.0 ± 1.73
    4.0 ± 2.65
    2.5 ± 1.29
    1.0 ± 1.41
    4.0 ± 99999
    5.0 ± 0.00
    1.8 ± 1.10
    4.3 ± 2.38
        pre-dose 5; n=3,3,4,2,1,4,5,8
    1.0 ± 1.00
    2.7 ± 2.08