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    Clinical Trial Results:
    A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with Respiratory Syncytial Virus (RSV) infection.

    Summary
    EudraCT number
    		 2015-002003-28
    Trial protocol
    		 SE   BE   ES   NL   IT  
    Global end of trial date
    10 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2018
    First version publication date
    23 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR107945
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02593851
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Sciences Ireland UC
    Sponsor organisation address
    Eastgate Village, Little Island, Ireland,
    Public contact
    Clinical Registry Group, Janssen Sciences Ireland UC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Sciences Ireland UC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001838-PIP01-15
    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
    10 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary purpose of this study was to evaluate the pharmacokinetics (PK) of JNJ-53718678 after multiple oral doses and the safety and tolerability of JNJ-53718678 when administered for 7 days in infants who were hospitalized with respiratory syncytial virus (RSV) infection.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.The safety assessments included clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), physical examinations and adverse events were reported throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    44
    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)
    44
    Children (2-11 years)
    0
    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
    		 A total of 61 subjects were screened and 44 were randomized and treated, out of them 7 subjects randomized in placebo and 37 subjects randomized in JNJ-53718678 treatment groups. All treated subjects completed the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JNJ-53718678 Low dose
    Arm description
    		 Subjects received JNJ-53718678 2 milligram per kilogram (mg/kg), 1.5 mg/kg and 1mg/kg once daily (qd) oral solution on Day 1 to Day 7 in Cohorts 1a ,2a and 3a respectively for each age group in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-53718678 2 mg/kg, 1.5 mg/kg and 1 mg/kg qd on Day 1 to Day 7 in Cohorts 1a ,2a and 3a respectively in Part 1 of study.

    Arm title
    		 JNJ-53718678 Mid dose
    Arm description
    		 Subjects received JNJ-53718678 6mg/kg, 4.5 mg/kg and 3mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1b ,2b and 3b respectively for each age group in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-53718678 6 mg/kg, 4.5 mg/kg and 3 mg/kg qd on Day 1 to Day 7 in Cohorts 1b ,2b and 3b respectively in Part 1 of study.

    Arm title
    		 JNJ-53718678 Cohort 1c
    Arm description
    		 Subjects received JNJ-53718678 8mg/kg qd oral solution on Day 1 to Day 7 in Cohort 1c in age group of greater than or equal (>=) to 6 months and less than or equal (<=) to 24 months of in Part 1 .
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-53718678 8 mg/kg qd on Day 1 to Day 7 in Part 1 of study.

    Arm title
    		 JNJ-53718678 High dose
    Arm description
    		 Subjects received JNJ-53718678 9mg/kg, 6 mg/kg and 5mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1d ,2c and 3c respectively for each age group in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-53718678 9 mg/kg, 6 mg/kg and 5 mg/kg qd on Day 1 to Day 7 in Cohorts 1d ,2c and 3c respectively in Part 1 of study.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matched JNJ-53718678 Placebo qd oral solution on Day 1 to Day 7 in all cohorts of Part 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matched JNJ-53718678 Placebo qd on Day 1 to Day 7 in all cohorts of Part 1 of study.

    Number of subjects in period 1
    		JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Started
    12
    12
    4
    9
    7
    Completed
    12
    12
    4
    9
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JNJ-53718678 Low dose
    Reporting group description
    		 Subjects received JNJ-53718678 2 milligram per kilogram (mg/kg), 1.5 mg/kg and 1mg/kg once daily (qd) oral solution on Day 1 to Day 7 in Cohorts 1a ,2a and 3a respectively for each age group in Part 1.

    Reporting group title
    JNJ-53718678 Mid dose
    Reporting group description
    		 Subjects received JNJ-53718678 6mg/kg, 4.5 mg/kg and 3mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1b ,2b and 3b respectively for each age group in Part 1.

    Reporting group title
    JNJ-53718678 Cohort 1c
    Reporting group description
    		 Subjects received JNJ-53718678 8mg/kg qd oral solution on Day 1 to Day 7 in Cohort 1c in age group of greater than or equal (>=) to 6 months and less than or equal (<=) to 24 months of in Part 1 .

    Reporting group title
    JNJ-53718678 High dose
    Reporting group description
    		 Subjects received JNJ-53718678 9mg/kg, 6 mg/kg and 5mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1d ,2c and 3c respectively for each age group in Part 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matched JNJ-53718678 Placebo qd oral solution on Day 1 to Day 7 in all cohorts of Part 1.

    Reporting group values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo Total
    Number of subjects
    		 12 12 4 9 7 44
    Title for AgeCategorical
    Units: subjects
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        InfantsAndToddlers (28 days - 23 months)
    		 12 12 4 9 7 44
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: months
        median (full range (min-max))
    		 4.4 (1.6 to 10.6) 3.6 (1.4 to 11.3) 8.7 (6.4 to 11.5) 4.8 (1.3 to 20.4) 3.4 (1.9 to 13.9) -
    Title for Gender
    Units: subjects
        Female
    		 4 6 2 5 6 23
        Male
    		 8 6 2 4 1 21
    Contact with Health-Care Provider (HCP) before hospitalization
    Units: Subjects
        Contact with HCP: No
    		 2 3 0 2 2 9
        Contact with HCP: Yes
    		 10 9 4 7 5 35
    Time between start of Respiratory Infection and First dosing
    Units: Days
        median (full range (min-max))
    		 5 (3 to 7) 5 (4 to 8) 5 (3 to 7) 7 (2 to 9) 5 (3 to 12) -
    RSV Viral Load at Baseline
    Units: Log10 copies per millilter
        median (full range (min-max))
    		 4.89 (2.14 to 7.96) 4.71 (2.14 to 8.3) 5.37 (2.88 to 6.66) 5.73 (5.24 to 7.12) 4.65 (3.69 to 5.64) -

    End points

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    End points reporting groups
    Reporting group title
    JNJ-53718678 Low dose
    Reporting group description
    		 Subjects received JNJ-53718678 2 milligram per kilogram (mg/kg), 1.5 mg/kg and 1mg/kg once daily (qd) oral solution on Day 1 to Day 7 in Cohorts 1a ,2a and 3a respectively for each age group in Part 1.

    Reporting group title
    JNJ-53718678 Mid dose
    Reporting group description
    		 Subjects received JNJ-53718678 6mg/kg, 4.5 mg/kg and 3mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1b ,2b and 3b respectively for each age group in Part 1.

    Reporting group title
    JNJ-53718678 Cohort 1c
    Reporting group description
    		 Subjects received JNJ-53718678 8mg/kg qd oral solution on Day 1 to Day 7 in Cohort 1c in age group of greater than or equal (>=) to 6 months and less than or equal (<=) to 24 months of in Part 1 .

    Reporting group title
    JNJ-53718678 High dose
    Reporting group description
    		 Subjects received JNJ-53718678 9mg/kg, 6 mg/kg and 5mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1d ,2c and 3c respectively for each age group in Part 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matched JNJ-53718678 Placebo qd oral solution on Day 1 to Day 7 in all cohorts of Part 1.

    Subject analysis set title
    Part 1: Cohort 1a
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (greater than or equal to [>=] 6 months and less than or equal to [<=] 24 months of age) received dose of 2 milligram per kilogram body weight (mg/kg) oral solution of JNJ-53718678, once daily (qd) on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 1b
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>= 6 months and <= 24 months of age) received dose of 6 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 1c
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>= 6 months and <= 24 months of age) received dose of 8 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 1d
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>= 6 months and <= 24 months of age) received dose of 9 mg/kg JNJ-53718678 oral solution or placebo qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 2a
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>= 3 months and less than [<] 6 months of age) received dose of 1.5 mg/kg oral solution of JNJ-53718678 qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 2b
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>=3 months and < 6 months of age) receive dose of 4.5 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 2c
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (>= 3 months and < 6 months of age) received dose of 6 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7

    Subject analysis set title
    Part 1: Cohort 3a
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (greater than (>) 1 month and < 3 months of age) received dose of 1 mg/kg oral solution of JNJ-53718678 qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 3b
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (> 1 month and < 3 months of age) received dose of 3 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7.

    Subject analysis set title
    Part 1: Cohort 3c
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects (> 1 month and < 3 months of age) received dose of 5 mg/kg oral solution of JNJ-53718678 or placebo qd on Day 1 to Day 7.

    Primary: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 [1]
    End point description
    The Cmax was the maximum plasma concentration. Pharmacokinetic (PK) Analysis population included all randomized subjects who have received at least one dose of study medication (JNJ-53718678), all subjects with available PK data were evaluated for PK parameters. Here, 99999 signifies that Geometric Coefficient of variation was not estimable' due to number of subjects. The population PK model simulated data are reported for this end point.
    End point type
    Primary
    End point timeframe
    Days 1, 3 and 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: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 Part 1: Cohort 1a Part 1: Cohort 1b Part 1: Cohort 1c Part 1: Cohort 1d Part 1: Cohort 2a Part 1: Cohort 2b Part 1: Cohort 2c Part 1: Cohort 3a Part 1: Cohort 3b Part 1: Cohort 3c
    Number of subjects analysed
    4
    4
    4
    4
    4
    4
    1
    4
    4
    4
    Units: nanogram per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Day 1
    546.8 ( 35.7 )
    1960.5 ( 58.1 )
    3346.9 ( 13.0 )
    2371.8 ( 70.8 )
    727.5 ( 68.7 )
    2533.2 ( 25.0 )
    2556.8 ( 99999 )
    374.2 ( 18.5 )
    958.2 ( 15.2 )
    1866.6 ( 51.7 )
        Day 3
    717.1 ( 31.3 )
    3300.4 ( 12.6 )
    4300.1 ( 11.5 )
    3255.1 ( 59.5 )
    880 ( 51.7 )
    3155.4 ( 27.3 )
    3500.9 ( 99999 )
    467.7 ( 5.3 )
    1483.2 ( 16.1 )
    2580.3 ( 22.7 )
        Day 7
    721.3 ( 31.2 )
    3304.2 ( 12.3 )
    4298.8 ( 11.2 )
    3389.4 ( 52.9 )
    938 ( 53.3 )
    3021.8 ( 41.2 )
    3131 ( 99999 )
    498 ( 13.2 )
    1671.2 ( 14.6 )
    3001.8 ( 25.1 )
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve over the dosing interval (AUCτau) of JNJ-53718678

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    End point title
    		 Area under the plasma concentration-time curve over the dosing interval (AUCτau) of JNJ-53718678 [2]
    End point description
    The AUCtau was the measure of the plasma drug concentration over the dosing interval. PK Analysis population included all randomized subjects who have received at least one dose of study medication (JNJ-53718678), all subjects with available PK data were evaluated for PK parameters. Here, 99999 signifies that Geometric Coefficient of variation was not estimable' due to number of subjects. The population PK model simulated data are reported for this end point.
    End point type
    Primary
    End point timeframe
    Days 1, 3 and 7
    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: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 Part 1: Cohort 1a Part 1: Cohort 1b Part 1: Cohort 1c Part 1: Cohort 1d Part 1: Cohort 2a Part 1: Cohort 2b Part 1: Cohort 2c Part 1: Cohort 3a Part 1: Cohort 3b Part 1: Cohort 3c
    Number of subjects analysed
    4
    4
    4
    4
    4
    4
    1
    4
    4
    4
    Units: nano gram*hour per milliliter (ng.hr/mL)
    geometric mean (geometric coefficient of variation)
        Day 1
    6047.2 ( 17.5 )
    18067.6 ( 59.7 )
    28655.3 ( 23.6 )
    24971.7 ( 43.8 )
    6658.4 ( 25.6 )
    26345.5 ( 11.8 )
    30484.8 ( 99999 )
    4495.6 ( 4.8 )
    14741.1 ( 13.9 )
    22800.2 ( 6.8 )
        Day 3
    7639 ( 24.2 )
    26416.7 ( 14.1 )
    33457.4 ( 32.1 )
    33246.5 ( 27.5 )
    8435.5 ( 16.6 )
    32392.7 ( 9.5 )
    39278 ( 99999 )
    5788.9 ( 15 )
    23434.6 ( 14 )
    34995 ( 19.6 )
        Day 7
    7738.8 ( 27.4 )
    26482.4 ( 15.1 )
    33528.7 ( 32.3 )
    35840.1 ( 22.6 )
    8620.9 ( 17.3 )
    28904.2 ( 32.3 )
    34980.3 ( 99999 )
    5827 ( 12.3 )
    26135.3 ( 14.1 )
    39627.7 ( 26.4 )
    No statistical analyses for this end point

    Primary: Minimum observed plasma concentration (Cmin) of JNJ-53718678

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    End point title
    		 Minimum observed plasma concentration (Cmin) of JNJ-53718678 [3]
    End point description
    The Cmin was the minimum observed plasma concentration. PK Analysis population included all randomized subjects who have received at least one dose of study medication (JNJ-53718678), all subjects with available PK data were evaluated for PK parameters. Here, 99999 signifies that Geometric Coefficient of variation was not estimable' due to number of subjects. The population PK model simulated data are reported for this end point.
    End point type
    Primary
    End point timeframe
    Days 1, 3 and 7
    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: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 Part 1: Cohort 1a Part 1: Cohort 1b Part 1: Cohort 1c Part 1: Cohort 1d Part 1: Cohort 2a Part 1: Cohort 2b Part 1: Cohort 2c Part 1: Cohort 3a Part 1: Cohort 3b Part 1: Cohort 3c
    Number of subjects analysed
    4
    4
    4
    4
    4
    4
    1
    4
    4
    4
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    81.4 ( 58.8 )
    155.5 ( 89.3 )
    244.1 ( 90.4 )
    333.2 ( 62.3 )
    88.3 ( 39.2 )
    319.8 ( 16.9 )
    428.6 ( 99999 )
    72.6 ( 41.1 )
    342.9 ( 14.3 )
    458.7 ( 54.9 )
        Day 3
    110.8 ( 73.6 )
    222.2 ( 67.3 )
    320.9 ( 94.1 )
    534 ( 72.2 )
    121.8 ( 46.9 )
    442.7 ( 19.7 )
    586.2 ( 99999 )
    103.9 ( 47.4 )
    586.6 ( 15.5 )
    810.7 ( 60.1 )
        Day 7
    114 ( 77.7 )
    225.7 ( 66.5 )
    323.9 ( 95.7 )
    615.9 ( 75.2 )
    124 ( 49.1 )
    363 ( 18.9 )
    517.3 ( 99999 )
    100.9 ( 46.3 )
    650.2 ( 15.5 )
    929 ( 62.1 )
    No statistical analyses for this end point

    Primary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events [4]
    End point description
    An adverse event was any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. The safety analysis set included all subjects who received any dose of JNJ-53718678 or placebo. Subjects in the safety analysis set were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Primary
    End point timeframe
    Up to Day 28
    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: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Subjects
    9
    10
    2
    7
    6
    No statistical analyses for this end point

    Secondary: Viral Load Area Under the Curve (VL AUC) from Baseline to Day 14

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    End point title
    		 Viral Load Area Under the Curve (VL AUC) from Baseline to Day 14
    End point description
    Viral load was determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC was calculated based on the trapezoidal method. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for respiratory syncytial virus ribonucleic acid (RSV RNA). Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 3, Day 7 and Day 14
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Log10copies.hour per milliliter
    median (full range (min-max))
        Baseline to Day 3
    165.54 (25.68 to 265.68)
    196.5 (87.36 to 361.56)
    165.42 (99.48 to 305.28)
    219.48 (149.16 to 262.32)
    231.36 (134.52 to 277.92)
        Baseline to Day 7
    304.44 (25.68 to 472.8)
    353.46 (144.24 to 874.56)
    467.88 (317.04 to 710.76)
    370.44 (225.84 to 590.64)
    417.84 (224.28 to 712.2)
        Baseline to Day 14
    398.76 (120.24 to 897.24)
    353.46 (144.24 to 1626.36)
    818.58 (496.8 to 980.4)
    522 (225.84 to 902.28)
    519.96 (224.28 to 1622.76)
    No statistical analyses for this end point

    Secondary: Change from Baseline Viral Load

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    End point title
    		 Change from Baseline Viral Load
    End point description
    Viral load was assessed at each assessment time point where a nasal sample was obtained. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment. Here, 'n'(number of subjects analyzed) signifies that the number of subjects evaluable for a specific time point. Here, 99999 signifies that LS mean and CI was not estimable' due to zero number of subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Log10copies/ml
    least squares mean (confidence interval 90%)
        Day 2
    -1.66 (-2.32 to -0.99)
    -1.15 (-1.81 to -0.49)
    -1.71 (-2.85 to -0.56)
    -1.42 (-2.21 to -0.63)
    -0.12 (-1 to 0.75)
        Day 3
    -2.56 (-3.17 to -1.95)
    -1.24 (-1.85 to -0.64)
    -1.56 (-2.62 to -0.51)
    -2.24 (-2.97 to -1.51)
    -0.33 (-1.14 to 0.48)
        Day 4
    -2.76 (-3.83 to -1.7)
    -2.39 (-3.52 to -1.26)
    -0.58 (-2.85 to 1.7)
    -3.4 (-4.63 to -2.17)
    -1.26 (-2.6 to 0.08)
        Day 5
    -4.27 (-5.42 to -3.12)
    -3.02 (-4.9 to -1.14)
    -2.32 (-5.67 to 1.03)
    -3.06 (-4.99 to -1.13)
    -2.72 (-4.49 to -0.96)
        Day 6
    -3.82 (-5.47 to -2.17)
    -5.8 (-10.29 to -1.3)
    99999 (99999 to 99999)
    -2.76 (-4.87 to -0.64)
    -4.02 (-5.93 to -2.1)
        Day 7
    -4.41 (-5.16 to -3.66)
    -4.14 (-4.89 to -3.4)
    -2.6 (-3.89 to -1.31)
    -3.96 (-4.85 to -3.06)
    -4.3 (-5.29 to -3.31)
        Day 14
    -3.96 (-4.83 to -3.09)
    -4.25 (-5.11 to -3.39)
    -4.15 (-5.64 to -2.66)
    -5.4 (-6.43 to -4.37)
    -3.61 (-4.76 to -2.47)
        Day 28
    -5.1 (-5.39 to -4.81)
    -5.1 (-5.39 to -4.81)
    -4.38 (-4.88 to -3.88)
    -4.77 (-5.11 to -4.42)
    -5.1 (-5.49 to -4.72)
    No statistical analyses for this end point

    Secondary: Peak Viral Load

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    End point title
    		 Peak Viral Load
    End point description
    Peak viral load was defined as maximum viral load value (in copies/ml), based on the qRT-PCR values throughout the study.Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Log10copies/ml
        median (full range (min-max))
    5.29 (3.35 to 7.96)
    6.81 (4.06 to 9.22)
    6.545 (3.35 to 7.84)
    6.23 (5.26 to 7.24)
    6.14 (5.04 to 7.35)
    No statistical analyses for this end point

    Secondary: Time To Peak Viral Load

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    End point title
    		 Time To Peak Viral Load
    End point description
    Time (hours) to peak viral load was defined as time in hours, up to the time at which the peak value is observed, in case identical peak values are identified at more than one time point, the first peak will be used. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    7
    7
    Units: hours
        median (full range (min-max))
    0 (0 to 351.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 20.4)
    0 (0 to 110.3)
    No statistical analyses for this end point

    Secondary: Time to Non-Detectability

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    End point title
    		 Time to Non-Detectability
    End point description
    Time to non-detectability was defined as the relative time in hours from the first dose of study drug until the first post dosing time point when the viral load reaches non-detectability in two consecutive nasal swabs. Subjects whose viral load does not reach non-detectability will be censored at their last measurement. Time to non-detectability is not defined if a subject does not have any post dosing viral load result. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: hours
        median (full range (min-max))
    109.95 (25.8 to 674.1)
    143.8 (42.5 to 676.1)
    495 (311.4 to 646.5)
    146.2 (72 to 671.5)
    146.2 (71.6 to 649.6)
    No statistical analyses for this end point

    Secondary: Length of Hospital Stay

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    End point title
    		 Length of Hospital Stay
    End point description
    Length of hospital stay was defined as the total number of hospitalization days due to RSV disease-related signs and symptoms from admission to discharge. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Days
        median (full range (min-max))
    4.15 (2.01 to 6.24)
    3.02 (2.02 to 6.1)
    2.77 (1.95 to 4)
    3.26 (2.06 to 6.27)
    3.23 (2.3 to 6.02)
    No statistical analyses for this end point

    Secondary: Time to Clinical Stability

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    End point title
    		 Time to Clinical Stability
    End point description
    Maximum (time to normalized heart rate [clinician]), time to normalized respiratory rate (clinician), time to end of supplemental oxygen, time to end of supplemental feeding (clinician) If time to normalized heart rate or time to normalized respiratory rate was censored, than time to clinical stability was censored as well.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: hours
        median (full range (min-max))
    67.3 (0 to 123.5)
    34 (0 to 118.8)
    21.25 (0 to 46.3)
    49.6 (30.5 to 96.2)
    56.7 (24.5 to 121.1)
    No statistical analyses for this end point

    Secondary: Time to end of Supplemental Oxygen

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    End point title
    		 Time to end of Supplemental Oxygen
    End point description
    Number of hours from first dose till last date/time of supplemental oxygen. Subjects who completed or withdrawn from the study prior to end of oxygen supplementation was censored at the date of completion or withdrawal.Duration of supplemental oxygen was defined as the total duration (hours) where Supplemental Oxygen requirement was reported. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: hours
        median (full range (min-max))
    45.2 (0 to 123.5)
    30.8 (0 to 93.4)
    16.4 (0 to 45.4)
    30.5 (0 to 96.2)
    27.3 (0 to 121.1)
    No statistical analyses for this end point

    Secondary: Time to Oxygen Saturation Greater Than (>) 92 Percent on Room Air

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    End point title
    		 Time to Oxygen Saturation Greater Than (>) 92 Percent on Room Air
    End point description
    Time to oxygen saturation > 92 % on room air was reported (after the last period of supplemental oxygen).The SpO2 % was assessed by the investigator during hospitalization. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: hours
        median (full range (min-max))
    47.45 (1.3 to 128.5)
    36.35 (6 to 130)
    27.6 (6.8 to 55.6)
    47.4 (4.5 to 172.8)
    34.1 (8.2 to 125.8)
    No statistical analyses for this end point

    Secondary: The Respiratory rate

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    End point title
    		 The Respiratory rate
    End point description
    The Respiratory rate (number of breaths per minute) was assessed by the investigator during hospitalization. Subjects in the "as treated infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment. Here, 99999 signifies that median and min-max was not estimable' due to zero number of subjects. Here, 'n' (number of subjects analyzed) signifies that the number of subjects evaluable for a specific time point.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: number of breaths per minute (brpm)
    median (full range (min-max))
        Day 1-Assessment 1 (n=12,12,4,9,7)
    53.5 (38 to 72)
    44 (33 to 51)
    51 (36 to 56)
    48 (28 to 64)
    47 (32 to 60)
        Day 1-Assessment 2 (n=12,9,4,7,6)
    45 (30 to 62)
    45 (31 to 60)
    42 (37 to 51)
    40 (24 to 52)
    39 (27 to 51)
        Day 2-Assessment 1 (n=12,12,4,9,7)
    44 (33 to 86)
    44 (27 to 60)
    46 (42 to 60)
    46 (28 to 60)
    45 (32 to 56)
        Day 2-Assessment 2 (n=12,11,4,6,7)
    41 (34 to 60)
    42 (27 to 54)
    45 (38 to 60)
    40 (36 to 48)
    42 (35 to 56)
        Day 3-Assessment 1 (n=12,12,4,9,7)
    48 (26 to 60)
    40 (26 to 65)
    44 (38 to 56)
    40 (28 to 48)
    40 (28 to 60)
        Day 3-Assessment 2 (n=10,11,3,7,6)
    41.5 (28 to 60)
    38 (24 to 60)
    60 (40 to 60)
    44 (30 to 52)
    40 (30 to 64)
        Day 4-Assessment 1 (n=9,8,2,7,5)
    51 (35 to 60)
    40 (28 to 50)
    56 (56 to 56)
    42 (20 to 62)
    44 (40 to 60)
        Day 4-Assessment 2 (n=8,4,1,2,3)
    36 (32 to 57)
    38 (32 to 45)
    40 (40 to 40)
    42 (40 to 44)
    44 (34 to 45)
        Day 5-Assessment 1 (n=8,3,1,3,3)
    40.5 (35 to 60)
    42 (36 to 48)
    56 (56 to 56)
    48 (30 to 56)
    30 (30 to 45)
        Day 5-Assessment 2 (n=5,1,0,1,3)
    42 (35 to 56)
    45 (45 to 45)
    99999 (99999 to 99999)
    40 (40 to 40)
    42 (33 to 48)
        Day 6-Assessment 1 (n=5,1,0,3,3)
    44 (35 to 48)
    40 (40 to 40)
    99999 (99999 to 99999)
    48 (31 to 48)
    45 (24 to 60)
        Day 6-Assessment 2 (n=5,1,0,2,2)
    46 (37 to 60)
    40 (40 to 40)
    99999 (99999 to 99999)
    43 (40 to 46)
    33 (30 to 36)
        Day 7-Assessment 1 (n=12,12,3,9,7)
    38.5 (30 to 56)
    38 (27 to 64)
    38 (38 to 46)
    38 (30 to 55)
    36 (30 to 40)
        Day 7-Assessment 2 (n=2,0,0,0,0)
    35.5 (35 to 36)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Day 14 (n=11,12,4,9,7)
    40 (32 to 45)
    33.5 (26 to 56)
    40 (27 to 44)
    36 (31 to 48)
    38 (30 to 60)
        Day 28 (n=12,12,4,9,7)
    40 (30 to 48)
    38 (30 to 52)
    29.5 (27 to 31)
    35 (28 to 50)
    39 (30 to 52)
    No statistical analyses for this end point

    Secondary: Body Temperature

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    End point title
    		 Body Temperature
    End point description
    The body temperature (degrees Celsius) was assessed by the investigator during hospitalization. Subjects in the "as treated infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment. Here, 99999 signifies that median and min-max was not estimable' due to zero number of subjects. Here, 'n' (number of subjects analyzed) signifies that the number of subjects evaluable for a specific time point.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: Degree Celsius
    median (full range (min-max))
        Day 1-Assessment 1 (n=12,12,4,9,7)
    36.5 (35.4 to 38.1)
    36.55 (36 to 37.3)
    36.35 (36 to 37.5)
    37 (36 to 37.7)
    36.5 (36.2 to 37)
        Day 1-Assessment 2 (n=12,10,4,7,6)
    36.6 (35.5 to 37.6)
    36.55 (35.6 to 38)
    36.25 (36.1 to 38.4)
    36.5 (36 to 37.8)
    36.6 (36.2 to 37.2)
        Day 2-Assessment 1 (n=12,12,4,9,7)
    36.6 (35.7 to 37.5)
    36.85 (36 to 37.4)
    36 (35.1 to 36)
    36.5 (36 to 37.4)
    36.4 (35.9 to 37.2)
        Day 2-Assessment 2 (n=12,12,4,6,7)
    36.45 (35.3 to 37.7)
    36.75 (36.1 to 37.8)
    36.1 (36 to 37)
    36.4 (36 to 36.6)
    36.6 (35.9 to 38)
        Day 3-Assessment 1 (n=12,12,4,9,7)
    36.5 (35.5 to 36.8)
    36.75 (36 to 37.2)
    36.05 (36 to 36.4)
    36.5 (36 to 37.2)
    36.7 (36 to 36.9)
        Day 3-Assessment 2 (n=10,12,3,7,6)
    36.35 (35.3 to 36.8)
    36.6 (36.1 to 37.2)
    36.3 (36.3 to 36.4)
    36.4 (36 to 37.2)
    36.65 (36.2 to 36.9)
        Day 4-Assessment 1 (n=9,8,2,7,5,)
    36.5 (36 to 36.9)
    36.65 (36 to 37.5)
    36.05 (35.8 to 36.3)
    36.5 (36 to 37.3)
    36.9 (36 to 37.3)
        Day 4-Assessment 2 (n=6,4,1,2,3)
    36.55 (36.2 to 37.1)
    36.4 (35.9 to 36.7)
    36.4 (36.4 to 36.4)
    36.65 (36 to 37.3)
    37 (36.8 to 37.2)
        Day 5-Assessment 1 (n=8,3,1,3,3)
    36.35 (35.8 to 36.9)
    36.3 (36 to 36.6)
    36.3 (36.3 to 36.3)
    36.4 (36 to 37)
    36.7 (36.3 to 36.7)
        Day 5-Assessment 2 (n=5,1,0,2,2)
    36.5 (36 to 37)
    36.4 (36.4 to 36.4)
    99999 (99999 to 99999)
    36.3 (36 to 36.6)
    36.7 (36.6 to 36.8)
        Day 6-Assessment 1 (n=5,1,0,3,3)
    36.6 (36.1 to 36.9)
    36.2 (36.2 to 36.2)
    99999 (99999 to 99999)
    36.6 (36 to 37.2)
    36.2 (35.9 to 36.4)
        Day 6-Assessment 2 (n=5,1,0,2,2)
    36.7 (35.3 to 36.9)
    37.3 (37.3 to 37.3)
    99999 (99999 to 99999)
    36.65 (36.2 to 37.1)
    36.3 (36.3 to 36.3)
        Day 7-Assessment 1 (n=12,12,4,9,6)
    36.55 (35.3 to 37.1)
    36.5 (35.6 to 37.5)
    36.05 (35.6 to 36.7)
    36.7 (36 to 37.3)
    36.4 (36 to 37)
        Day 7-Assessment 2 (n=2,0,0,0,0)
    36.45 (36.4 to 36.5)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Day 14 (n=12,12,4,9,7)
    36.45 (35.8 to 37.1)
    36.6 (35.9 to 37.3)
    36.25 (35.9 to 36.8)
    36.6 (36 to 37.6)
    36.4 (36.1 to 38)
        Day 28 (n=12,12,4,9,7)
    36.35 (36 to 37.2)
    36.25 (35.1 to 37.3)
    36.2 (36 to 36.8)
    36.4 (35.8 to 37.6)
    36.4 (36.2 to 36.7)
    No statistical analyses for this end point

    Secondary: End of Supplemental Feeding - Clinician

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    End point title
    		 End of Supplemental Feeding - Clinician
    End point description
    Number of hours from first dose till last date/time point of supplemental feeding (based on the clinician COA/bid) where supplemental feeding was given via ‘nasogastric tube’ and/or ‘intravenous’ and answered the question: How is the patient feeding in the past 12 hours? from below options; Breast, bottle, or spoon/fork feeding or self-feeding ; Nasogastric tube; Intravenous and Patient did not feed during past 12 hours. Subjects in the "as treated-infected" analysis set included all randomized subjects who have received at least one dose of JNJ-53718678 and who were PCR positive at baseline for RSV RNA. Subjects in this analysis population were categorized by actual treatment received, irrespective of the randomization assignment
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Number of subjects analysed
    12
    12
    4
    9
    7
    Units: hours
        median (full range (min-max))
    0 (0 to 18)
    0 (0 to 53)
    0 (0 to 46.3)
    0 (0 to 71.8)
    0 (0 to 56.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events were reported up to Day 28
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    JNJ-53718678 Low dose
    Reporting group description
    		 Subjects received JNJ 53718678 2 milligram per kilogram (mg/kg), 1.5 mg/kg and 1mg/kg once daily (qd) oral solution on Day 1 to Day 7 in Cohorts 1a ,2a and 3a respectively for each age group in part 1.

    Reporting group title
    JNJ-53718678 Mid dose
    Reporting group description
    		 Subjects received JNJ 53718678 6mg/kg, 4.5 mg/kg and 3mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1b ,2b and 3b respectively for each age group in part 1.

    Reporting group title
    JNJ-53718678 Cohort 1c
    Reporting group description
    		 Subjects received JNJ 53718678 8mg/kg qd oral solution on Day 1 to Day 7 in Cohort 1c in age group of greater than or equal (>=) to 6 months and less than or equal (<=) to 24 months of in part 1 .

    Reporting group title
    JNJ-53718678 High dose
    Reporting group description
    		 Subjects received JNJ 53718678 9mg/kg, 6 mg/kg and 5mg/kg qd oral solution on Day 1 to Day 7 in Cohorts 1d ,2c and 3c respectively for each age group in part 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matched JNJ 53718678 Placebo qd oral solution on Day 1 to Day 7 in all cohorts of Part 1.

    Serious adverse events
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 JNJ-53718678 Low dose JNJ-53718678 Mid dose JNJ-53718678 Cohort 1c JNJ-53718678 High dose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    10 / 12 (83.33%)
    2 / 4 (50.00%)
    7 / 9 (77.78%)
    6 / 7 (85.71%)
    Investigations
    QRS Axis Abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Leukocytosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    1 / 7 (14.29%)
         occurrences all number
    2
    0
    0
    3
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Eye disorders
    Dacryostenosis Acquired
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    0
    4
    2
    Faeces Soft
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    2 / 4 (50.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    9
    3
    0
    0
    Lip Discolouration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Teething
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    2 / 4 (50.00%)
    4 / 9 (44.44%)
    4 / 7 (57.14%)
         occurrences all number
    0
    6
    2
    7
    6
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    Nasal Obstruction
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    0
    0
    1
    Pharyngeal Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory Symptom
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Diaper
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    2
    Dry Skin
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
         occurrences all number
    0
    1
    0
    1
    2
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Ear Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Genital Candidiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lower Respiratory Tract Infection Bacterial
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oral Candidiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Otitis Media Acute
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Respiratory Tract Infection Bacterial
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    4 / 12 (33.33%)
    0 / 4 (0.00%)
    3 / 9 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    1
    4
    0
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Nov 2016
    The overall reason for the amendment was to supplement the number of subjects in the study to better estimate the antiviral effects of JNJ-53718678 and its effects on the clinical course of respiratory syncytial virus (RSV), as included in the secondary objectives and endpoints. In relation to this, certain design elements of the study including but not limited to, frequency of assessments had been adapted. Establishing the antiviral effects of JNJ 53718678 and its effects on the clinical course of RSV will potentially expedite its development to serve an unmet clinical need.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Nov 2017
    Study was put on hold in March 2017 and then terminated in Nov 2017.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In Part 2 only 1 subject (placebo) had enrolled at time of premature study termination, data of Part 1 and 2 placebo subjects was combined hence, viral load data was insufficient for an accurate evaluation of the antiviral effect of JNJ-53718678.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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