Trial Outcomes & Findings for Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005) (NCT NCT04086472)
NCT ID: NCT04086472
Last Updated: 2022-09-14
Results Overview
The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
Results posted on
2022-09-14
Participant Flow
Healthy adult male and female participants were recruited at a single study site in the United Kingdom.
Participant milestones
| Measure |
MK-1654 100 mg
Participants receive a single intravenous (IV) infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
Received MK-1654 or Placebo
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
Inoculated With Respiratory Syncytial Virus (RSV) A Memphis 37b
|
14
|
14
|
14
|
13
|
15
|
|
Overall Study
Not Inoculated
|
2
|
2
|
2
|
3
|
1
|
|
Overall Study
COMPLETED
|
12
|
14
|
14
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
MK-1654 100 mg
Participants receive a single intravenous (IV) infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Various reasons
|
2
|
0
|
0
|
3
|
1
|
Baseline Characteristics
Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
Baseline characteristics by cohort
| Measure |
MK-1654 100 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=16 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.4 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
27.1 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
27.6 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
26.4 Years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
25.3 Years
STANDARD_DEVIATION 4.1 • n=21 Participants
|
27.4 Years
STANDARD_DEVIATION 6.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation.
Outcome measures
| Measure |
MK-1654 100 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=14 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=15 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Viral Load-time Curve (VL-AUC)
|
19.94 log10 copies-/ml*days
Interval 12.11 to 27.78
|
14.74 log10 copies-/ml*days
Interval 6.9 to 22.58
|
16.44 log10 copies-/ml*days
Interval 8.89 to 23.99
|
15.33 log10 copies-/ml*days
Interval 7.5 to 23.17
|
21.25 log10 copies-/ml*days
Interval 13.96 to 28.55
|
SECONDARY outcome
Timeframe: 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
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.
Outcome measures
| Measure |
MK-1654 100 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=14 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=13 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=15 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection
|
53.85 Percentage of Participants
Interval 25.13 to 80.78
|
30.77 Percentage of Participants
Interval 9.09 to 61.43
|
35.71 Percentage of Participants
Interval 12.76 to 64.86
|
30.77 Percentage of Participants
Interval 9.09 to 61.43
|
53.33 Percentage of Participants
Interval 26.59 to 78.73
|
SECONDARY outcome
Timeframe: Up to 187 daysPopulation: All participants who received any study intervention are included.
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.
Outcome measures
| Measure |
MK-1654 100 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=16 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
11 Participants
|
12 Participants
|
12 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 187 daysPopulation: All participants who received any study intervention are included.
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.
Outcome measures
| Measure |
MK-1654 100 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=16 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With a Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose and Days 1 (1, 2, and 4 hours postdose), 8, 15, 29, 40, and 57Population: All randomized participants who received MK-1654 and had no major protocol deviations are included.
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.
Outcome measures
| Measure |
MK-1654 100 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Serum Concentration of MK-1654
Predose
|
0.0369 µg/mL
Standard Deviation 0.148
|
0.00 µg/mL
Standard Deviation 0.00
|
0.00 µg/mL
Standard Deviation 0.00
|
0.00 µg/mL
Standard Deviation 0.00
|
—
|
|
Serum Concentration of MK-1654
Day 1, 1 hour postdose
|
16.4 µg/mL
Standard Deviation 3.13
|
36.0 µg/mL
Standard Deviation 6.65
|
62.6 µg/mL
Standard Deviation 16.8
|
134 µg/mL
Standard Deviation 45.1
|
—
|
|
Serum Concentration of MK-1654
Day 1, 2 hours postdose
|
34.3 µg/mL
Standard Deviation 6.42
|
72.6 µg/mL
Standard Deviation 12.5
|
125 µg/mL
Standard Deviation 25.7
|
298 µg/mL
Standard Deviation 46.8
|
—
|
|
Serum Concentration of MK-1654
Day 1, 4 hours postdose
|
33.3 µg/mL
Standard Deviation 6.19
|
68.8 µg/mL
Standard Deviation 11.5
|
122 µg/mL
Standard Deviation 26.9
|
287 µg/mL
Standard Deviation 46.0
|
—
|
|
Serum Concentration of MK-1654
Day 8
|
16.0 µg/mL
Standard Deviation 2.54
|
33.0 µg/mL
Standard Deviation 5.48
|
56.7 µg/mL
Standard Deviation 12.8
|
140 µg/mL
Standard Deviation 24.1
|
—
|
|
Serum Concentration of MK-1654
Day 15
|
14.5 µg/mL
Standard Deviation 2.49
|
29.1 µg/mL
Standard Deviation 4.19
|
47.6 µg/mL
Standard Deviation 8.57
|
123 µg/mL
Standard Deviation 21.6
|
—
|
|
Serum Concentration of MK-1654
Day 29
|
11.9 µg/mL
Standard Deviation 2.11
|
23.1 µg/mL
Standard Deviation 3.06
|
38.5 µg/mL
Standard Deviation 6.99
|
103 µg/mL
Standard Deviation 16.0
|
—
|
|
Serum Concentration of MK-1654
Day 40
|
10.2 µg/mL
Standard Deviation 1.74
|
21.4 µg/mL
Standard Deviation 3.18
|
35.6 µg/mL
Standard Deviation 7.16
|
88.5 µg/mL
Standard Deviation 13.4
|
—
|
|
Serum Concentration of MK-1654
Day 57
|
9.46 µg/mL
Standard Deviation 2.01
|
18.7 µg/mL
Standard Deviation 2.60
|
32.3 µg/mL
Standard Deviation 6.14
|
79.5 µg/mL
Standard Deviation 15.5
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 40, and 57Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available for the time point are included.
RSV serum neutralization titers were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
MK-1654 100 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 Participants
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=16 Participants
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Concentration of RSV Serum Neutralizing Antibody Titers
Day 1, Predose
|
669.1 Titers
Interval 487.5 to 918.4
|
699.3 Titers
Interval 530.9 to 921.0
|
954.0 Titers
Interval 606.1 to 1501.4
|
893.8 Titers
Interval 649.0 to 1230.8
|
837.4 Titers
Interval 567.9 to 1234.9
|
|
Concentration of RSV Serum Neutralizing Antibody Titers
Day 1, 2 hours postdose
|
11137.6 Titers
Interval 8884.8 to 13961.7
|
24836.1 Titers
Interval 21971.4 to 28074.3
|
41544.8 Titers
Interval 33688.4 to 51233.3
|
100163.5 Titers
Interval 84649.3 to 118521.1
|
1225.4 Titers
Interval 621.0 to 2418.3
|
|
Concentration of RSV Serum Neutralizing Antibody Titers
Day 29
|
4727.2 Titers
Interval 4026.3 to 5550.0
|
8135.8 Titers
Interval 6945.6 to 9530.0
|
13263.2 Titers
Interval 11050.6 to 15918.9
|
31367.8 Titers
Interval 26876.0 to 36610.3
|
1037.1 Titers
Interval 673.9 to 1596.1
|
|
Concentration of RSV Serum Neutralizing Antibody Titers
Day 40
|
4517.1 Titers
Interval 3899.6 to 5232.2
|
8357.6 Titers
Interval 7073.1 to 9875.4
|
13510.9 Titers
Interval 11564.1 to 15785.4
|
27935.5 Titers
Interval 19429.8 to 40164.6
|
1540.4 Titers
Interval 1025.9 to 2313.3
|
|
Concentration of RSV Serum Neutralizing Antibody Titers
Day 57
|
4377.8 Titers
Interval 3338.4 to 5740.9
|
5531.9 Titers
Interval 4315.0 to 7092.1
|
11557.9 Titers
Interval 9428.4 to 14168.4
|
22209.6 Titers
Interval 17585.6 to 28049.5
|
1500.2 Titers
Interval 908.7 to 2476.8
|
Adverse Events
MK-1654 100 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MK-1654 200 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MK-1654 300 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MK-1654 900 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-1654 100 mg
n=16 participants at risk
Participants receive a single IV infusion of MK-1654 100 mg on Day 1.
|
MK-1654 200 mg
n=16 participants at risk
Participants receive a single IV infusion of MK-1654 200 mg on Day 1.
|
MK-1654 300 mg
n=16 participants at risk
Participants receive a single IV infusion of MK-1654 300 mg on Day 1.
|
MK-1654 900 mg
n=16 participants at risk
Participants receive a single IV infusion of MK-1654 900 mg on Day 1.
|
Placebo
n=16 participants at risk
Participants receive a single IV infusion of placebo on Day 1.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Odynophagia
|
12.5%
2/16 • Number of events 2 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
General disorders
Catheter site bruise
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Oral herpes
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
12.5%
2/16 • Number of events 2 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
18.8%
3/16 • Number of events 4 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
18.8%
3/16 • Number of events 3 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
12.5%
2/16 • Number of events 2 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Investigations
Body temperature increased
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Investigations
C-reactive protein increased
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 2 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Number of events 8 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
37.5%
6/16 • Number of events 6 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
31.2%
5/16 • Number of events 6 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
31.2%
5/16 • Number of events 7 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
18.8%
3/16 • Number of events 3 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 7 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
18.8%
3/16 • Number of events 4 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
2/16 • Number of events 2 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
|
Vascular disorders
Phlebitis
|
6.2%
1/16 • Number of events 1 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
0.00%
0/16 • Up to 187 days
All participants who received a dose of any study intervention are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER