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    Clinical Trial Results:
    A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated with Experimental Respiratory Syncytial Virus

    Summary
    EudraCT number
    		 2018-003347-28
    Trial protocol
    		 GB  
    Global end of trial date
    14 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2021
    First version publication date
    05 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-1654-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04086472
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine if a single intravenous (IV) dose of MK-1654 when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with respiratory syncytial virus [RSV] A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of MK-1654 given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2019
    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
    United Kingdom: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    0
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy adult male and female participants were recruited at a single study site in the United Kingdom.

    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, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-1654 100 mg
    Arm description
    		 Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of MK-1654 administered via IV infusion.

    Investigational medicinal product name
    RSV-A Memphis 37b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

    Arm title
    		 MK-1654 200 mg
    Arm description
    		 Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSV-A Memphis 37b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Approximately 4Log10 PFU/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

    Investigational medicinal product name
    MK-1654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of MK-1654 administered via IV infusion.

    Arm title
    		 MK-1654 300 mg
    Arm description
    		 Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of MK-1654 administered via IV infusion.

    Investigational medicinal product name
    RSV-A Memphis 37b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Approximately 4Log10 PFU/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

    Arm title
    		 MK-1654 900 mg
    Arm description
    		 Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of MK-1654 administered via IV infusion.

    Investigational medicinal product name
    RSV-A Memphis 37b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Approximately 4Log10 PFU/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

    Arm title
    		 Placebo
    Arm description
    		 Participants receive a single IV infusion of placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo (0.9% sodium chloride, United States Pharmacopeia [USP] sterile saline) administered via IV infusion.

    Investigational medicinal product name
    RSV-A Memphis 37b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Approximately 4Log10 PFU/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

    Number of subjects in period 1
    		MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Started
    16
    16
    16
    16
    16
    Received MK-1654 or Placebo
    16
    16
    16
    16
    16
    Inoculated w/ RSV A Memphis 37b
    14
    14
    14
    13
    15
    Not Inoculated
    2 [1]
    2 [2]
    2 [3]
    3 [4]
    1 [5]
    Completed
    12
    14
    14
    13
    14
    Not completed
    4
    2
    2
    3
    2
         Consent withdrawn by subject
    1
    1
    1
    -
    -
         Physician decision
    -
    1
    1
    -
    -
         Various reasons
    2
    -
    -
    3
    1
         Lost to follow-up
    1
    -
    -
    -
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: A subset of participants received MK-1654 or placebo, but were not inoculated with RSV A Memphis 37b.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: A subset of participants received MK-1654 or placebo, but were not inoculated with RSV A Memphis 37b.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: A subset of participants received MK-1654 or placebo, but were not inoculated with RSV A Memphis 37b.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: A subset of participants received MK-1654 or placebo, but were not inoculated with RSV A Memphis 37b.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: A subset of participants received MK-1654 or placebo, but were not inoculated with RSV A Memphis 37b.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MK-1654 100 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 100 mg on Day 1.

    Reporting group title
    MK-1654 200 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 200 mg on Day 1.

    Reporting group title
    MK-1654 300 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 300 mg on Day 1.

    Reporting group title
    MK-1654 900 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 900 mg on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive a single IV infusion of placebo on Day 1.

    Reporting group values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo Total
    Number of subjects
    		 16 16 16 16 16 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 16 16 16 16 80
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 30.4 ( 6.9 ) 27.1 ( 8.3 ) 27.6 ( 8.7 ) 26.4 ( 4.5 ) 25.3 ( 4.1 ) -
    Sex: Female, Male
    Units:
        Female
    		 4 5 12 5 9 35
        Male
    		 12 11 4 11 7 45
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 1 2 0 1 1 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 1 0 0 0 1
        White
    		 14 11 14 15 14 68
        More than one race
    		 1 2 2 0 1 6
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 0 0 1
        Not Hispanic or Latino
    		 15 16 16 16 16 79
        Unknown or Not Reported
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    MK-1654 100 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 100 mg on Day 1.

    Reporting group title
    MK-1654 200 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 200 mg on Day 1.

    Reporting group title
    MK-1654 300 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 300 mg on Day 1.

    Reporting group title
    MK-1654 900 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 900 mg on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive a single IV infusion of placebo on Day 1.

    Primary: Area Under the Viral Load-time Curve (VL-AUC)

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    End point title
    		 Area Under the Viral Load-time Curve (VL-AUC)
    End point description
    The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation. All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
    End point type
    Primary
    End point timeframe
    10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Number of subjects analysed
    13
    13
    14
    13
    15
    Units: log10 copies-/ml*days
        least squares mean (confidence interval 95%)
    19.94 (12.11 to 27.78)
    14.74 (6.90 to 22.58)
    16.44 (8.89 to 23.99)
    15.33 (7.50 to 23.17)
    21.25 (13.96 to 28.55)
    Statistical analysis title
    		 MK-1654 100 mg vs. Placebo
    Comparison groups
    MK-1654 100 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.808
    Method
    		 ANOVA
    Parameter type
    		 Least squares (LS) Mean Difference
    Point estimate
    -1.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.25
         upper limit
    		 7.64
    Statistical analysis title
    		 MK-1654 200 mg vs. Placebo
    Comparison groups
    MK-1654 200 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.229
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -6.51
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -15.46
         upper limit
    		 2.43
    Statistical analysis title
    		 MK-1654 300 mg vs. Placebo
    Comparison groups
    MK-1654 300 mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.363
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -4.81
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -13.58
         upper limit
    		 3.96
    Statistical analysis title
    		 MK-16654 900 mg vs. Placebo
    Comparison groups
    MK-1654 900 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.273
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.92
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.87
         upper limit
    		 3.02

    Secondary: Percentage of Participants with Symptomatic Respiratory Syncytial Virus (RSV) Infection

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    End point title
    		 Percentage of Participants with Symptomatic Respiratory Syncytial Virus (RSV) Infection
    End point description
    Symptomatic RSV infection is defined as presence of at least 2 quantifiable RT-qPCR at ≥2 consecutive days, plus symptoms of either any grade from 2 different symptoms from the Subject Symptom Card (SSC) or at least one Grade 2 symptom from ≥1 respiratory categories. All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
    End point type
    Secondary
    End point timeframe
    10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Number of subjects analysed
    13
    13
    14
    13
    15
    Units: Percentage of Participants
        number (confidence interval 95%)
    53.85 (25.13 to 80.78)
    30.77 (9.09 to 61.43)
    35.71 (12.76 to 64.86)
    30.77 (9.09 to 61.43)
    53.33 (26.59 to 78.73)
    Statistical analysis title
    		 MK-1654 100 mg vs. Placebo
    Comparison groups
    MK-1654 100 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.57
         upper limit
    		 37.78
    Statistical analysis title
    		 MK-1654 200 mg vs. Placebo
    Comparison groups
    MK-1654 200 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -22.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -56.7
         upper limit
    		 15.53
    Statistical analysis title
    		 MK-1654 300 mg vs. Placebo
    Comparison groups
    MK-1654 300 mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -17.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.09
         upper limit
    		 20.01
    Statistical analysis title
    		 MK-1654 900 mg vs. Placebo
    Comparison groups
    MK-1654 900 mg v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -22.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -56.7
         upper limit
    		 15.53

    Secondary: Number of Participants with an Adverse Event (AE)

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    End point title
    		 Number of Participants with an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All participants who received any study intervention are included.
    End point type
    Secondary
    End point timeframe
    Up to 187 days
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Number of subjects analysed
    16
    16
    16
    16
    16
    Units: Participants
    11
    12
    12
    8
    11
    No statistical analyses for this end point

    Secondary: Number of Participants with a Serious Adverse Event (SAE)

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    End point title
    		 Number of Participants with a Serious Adverse Event (SAE)
    End point description
    An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. All participants who received any study intervention are included.
    End point type
    Secondary
    End point timeframe
    Up to 187 days
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Number of subjects analysed
    16
    16
    16
    16
    16
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Concentration of MK-1654

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    End point title
    		 Serum Concentration of MK-1654 [1]
    End point description
    The post-dosing concentration of MK-1654 will be determined in serum. On Day 1, 3 samples will be taken at 1, 2, and 4 hours after administration. All randomized participants who received MK-1654 and had no major protocol deviations are included (each data point is based on 16 participants unless indicated otherwise).
    End point type
    Secondary
    End point timeframe
    Predose and Days 1 (1, 2, and 4 hours postdose), 8, 15, 29, 40, and 57
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Serum concentration of MK-1654 was not evaluated in the placebo arm.
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg
    Number of subjects analysed
    16
    16
    16
    16
    Units: µg/mL
    arithmetic mean (standard deviation)
        Predose (n=16,15,16,16)
    0.0369 ( 0.148 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Day 1, 1 hour postdose
    16.4 ( 3.13 )
    36.0 ( 6.65 )
    62.6 ( 16.8 )
    134 ( 45.1 )
        Day 1, 2 hours postdose
    34.3 ( 6.42 )
    72.6 ( 12.5 )
    125 ( 25.7 )
    298 ( 46.8 )
        Day 1, 4 hours postdose
    33.3 ( 6.19 )
    68.8 ( 11.5 )
    122 ( 26.9 )
    287 ( 46.0 )
        Day 8
    16.0 ( 2.54 )
    33.0 ( 5.48 )
    56.7 ( 12.8 )
    140 ( 24.1 )
        Day 15
    14.5 ( 2.49 )
    29.1 ( 4.19 )
    47.6 ( 8.57 )
    123 ( 21.6 )
        Day 29 (n=14,15,14,14)
    11.9 ( 2.11 )
    23.1 ( 3.06 )
    38.5 ( 6.99 )
    103 ( 16.0 )
        Day 40 (n=12,14,14,13)
    10.2 ( 1.74 )
    21.4 ( 3.18 )
    35.6 ( 7.16 )
    88.5 ( 13.4 )
        Day 57 (n=11,11,11,8)
    9.46 ( 2.01 )
    18.7 ( 2.60 )
    32.3 ( 6.14 )
    79.5 ( 15.5 )
    No statistical analyses for this end point

    Secondary: Concentration of RSV Serum Neutralizing Antibody Titers

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    End point title
    		 Concentration of RSV Serum Neutralizing Antibody Titers
    End point description
    RSV serum neutralization titers were determined by enzyme-linked immunosorbent assay (ELISA). All randomized participants who received one correct dose of study drug corresponding to the treatment group the participant was randomized into, had data available for the time point, and had no major protocol deviations are included (each data point is based on 16 participants unless indicated otherwise).
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 40, and 57
    End point values
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Number of subjects analysed
    16
    16
    16
    16
    16
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1, Predose (n=16,15,14,16,15)
    669.1 (487.5 to 918.4)
    699.3 (530.9 to 921.0)
    954.0 (606.1 to 1501.4)
    893.8 (649.0 to 1230.8)
    837.4 (567.9 to 1234.9)
        Day 1, 2 hours postdose (n=16,16,15,16,16)
    11137.6 (8884.8 to 13961.7)
    24836.1 (21971.4 to 28074.3)
    41544.8 (33688.4 to 51233.3)
    100163.5 (84649.3 to 118521.1)
    1225.4 (621.0 to 2418.3)
        Day 29 (n=14,15,14,14,15)
    4727.2 (4026.3 to 5550.0)
    8135.8 (6945.6 to 9530.0)
    13263.2 (11050.6 to 15918.9)
    31367.8 (26876.0 to 36610.3)
    1037.1 (673.9 to 1596.1)
        Day 40 (n=13,14,14,13,15)
    4517.1 (3899.6 to 5232.2)
    8357.6 (7073.1 to 9875.4)
    13510.9 (11564.1 to 15785.4)
    27935.5 (19429.8 to 40164.6)
    1540.4 (1025.9 to 2313.0)
        Day 57 (n=11,11,11,8,12)
    4377.8 (3338.4 to 5740.9)
    5531.9 (4315.0 to 7092.1)
    11557.9 (9428.4 to 14168.4)
    22209.6 (17585.6 to 28049.5)
    1500.2 (908.7 to 2476.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 187 days
    Adverse event reporting additional description
    All participants who received a dose of any study intervention are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    MK-1654 100 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 100 mg on Day 1.

    Reporting group title
    MK-1654 200 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 200 mg on Day 1.

    Reporting group title
    MK-1654 300 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 300 mg on Day 1.

    Reporting group title
    MK-1654 900 mg
    Reporting group description
    		 Participants receive a single IV infusion of MK-1654 900 mg on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive a single IV infusion of placebo on Day 1.

    Serious adverse events
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MK-1654 100 mg MK-1654 200 mg MK-1654 300 mg MK-1654 900 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 16 (68.75%)
    12 / 16 (75.00%)
    12 / 16 (75.00%)
    8 / 16 (50.00%)
    11 / 16 (68.75%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Catheter site bruise
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    4
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasal injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 16 (37.50%)
    6 / 16 (37.50%)
    5 / 16 (31.25%)
    5 / 16 (31.25%)
    3 / 16 (18.75%)
         occurrences all number
    8
    6
    6
    7
    3
    Presyncope
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Back pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Bronchitis viral
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    3 / 16 (18.75%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    1
    4
    3
    1
    2
    Viral pharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2019
    The primary reasons for the amendment were to remove template text and to clarify that participants should avoid vulnerable individuals after completing the study.
    14 Aug 2020
    The primary reason for the amendment (approved 03-Dec-2020, after study completion) was to clarify that leftover main study nasal swab wash would be stored for future research.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
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