Trial Outcomes & Findings for A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002) (NCT NCT02055547)
NCT ID: NCT02055547
Last Updated: 2020-07-02
Results Overview
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
From Day 1 through post-trial visit (Up to 8 weeks)
Results posted on
2020-07-02
Participant Flow
Participants were recruited at one clinical site in Belgium.
An optional Panel G in Part 2 per protocol did not occur. Period-level data were not collected for each treatment sequence.
Participant milestones
| Measure |
Part 1 - Panel A - MK-8521 100μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and matching placebo (PBO) in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel A - PBO > MK-8521 300μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel A - MK-8521 100μg > MK-8521 300μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > PBO > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, PBO in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > 200μg > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > MK-8521 200μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - PBO > MK-8521 200μg > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received PBO in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 2 - Panel C - MK-8521 50μg > MK-8521 72μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 50μg Days 1 to 5 and MK-8521 72μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panel D - MK-8521 100μg > MK-8521 150μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panel E - MK-8521 125μg > MK-8521 150μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panels C, D, and E - Pooled PBO
Healthy young lean male participants received matching placebo for MK-8521 once daily for 10 days.
|
Part 2 - Panel F - MK-8521 72μg > MK-8521 125μg or PBO
Obese male participants of 45 to 65 years of age received a single dose of MK-8521 72μg Days 1 to 7 and MK-8521 125μg Days 8 to 14 or placebo in a single treatment period.
|
Part 2 - Panel F - Placebo
Obese male participants of 45 to 65 years of age received a single dose of matching placebo for MK-8521 Days 1 to 14.
|
Part 3 - Panel H - MK-8521 125μg > 35μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 35μg > PBO > MK-8521 125μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, PBO in the second treatment period, and 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - PBO > MK-8521 125μg > 35μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - PBO > MK-8521 35μg > 125μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and MK-8521 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 125μg > PBO > MK-8521 35μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, PBO in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 35μg > 125μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
5
|
2
|
2
|
2
|
2
|
6
|
6
|
6
|
6
|
6
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
2
|
1
|
1
|
0
|
6
|
4
|
5
|
5
|
6
|
2
|
1
|
2
|
1
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
0
|
1
|
1
|
2
|
0
|
2
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 - Panel A - MK-8521 100μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and matching placebo (PBO) in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel A - PBO > MK-8521 300μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel A - MK-8521 100μg > MK-8521 300μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg in the first treatment period, and MK-8521 300μg in the second treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > PBO > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, PBO in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > 200μg > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - MK-8521 150μg > MK-8521 200μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 150μg in the first treatment period, MK-8521 200μg in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 1 - Panel B - PBO > MK-8521 200μg > MK-8521 175μg
Healthy male participants of 18 to 45 years of age received PBO in the first treatment period, MK-8521 200μg in the second treatment period, and MK-8521 175μg in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 2 - Panel C - MK-8521 50μg > MK-8521 72μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 50μg Days 1 to 5 and MK-8521 72μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panel D - MK-8521 100μg > MK-8521 150μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 100μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panel E - MK-8521 125μg > MK-8521 150μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg Days 1 to 5 and MK-8521 150μg Days 6 to 10 in a single treatment period.
|
Part 2 - Panels C, D, and E - Pooled PBO
Healthy young lean male participants received matching placebo for MK-8521 once daily for 10 days.
|
Part 2 - Panel F - MK-8521 72μg > MK-8521 125μg or PBO
Obese male participants of 45 to 65 years of age received a single dose of MK-8521 72μg Days 1 to 7 and MK-8521 125μg Days 8 to 14 or placebo in a single treatment period.
|
Part 2 - Panel F - Placebo
Obese male participants of 45 to 65 years of age received a single dose of matching placebo for MK-8521 Days 1 to 14.
|
Part 3 - Panel H - MK-8521 125μg > 35μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 35μg > PBO > MK-8521 125μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, PBO in the second treatment period, and 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - PBO > MK-8521 125μg > 35μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - PBO > MK-8521 35μg > 125μg
Healthy male participants of 18 to 45 years of age received a single dose of PBO in the first treatment period, MK-8521 35μg (low dose) in the second treatment period, and MK-8521 125μg (high dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 125μg > PBO > MK-8521 35μg
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 125μg (high dose) in the first treatment period, PBO in the second treatment period, and MK-8521 35μg (low dose) in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
Part 3 - Panel H - MK-8521 35μg > 125μg > PBO
Healthy male participants of 18 to 45 years of age received a single dose of MK-8521 35μg (low dose) in the first treatment period, MK-8521 125μg (high dose) in the second treatment period, and PBO in the third treatment period. There was a minimum of a 7-day washout period between treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)
Baseline characteristics by cohort
| Measure |
Part 1 - 3, Panel A, B, C, D, E, F, and H
n=61 Participants
All participants who received a dose of MK-8521 or placebo in any study period.
|
|---|---|
|
Age, Continuous
|
33.5 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through post-trial visit (Up to 8 weeks)Population: The analysis population included all participants in Part 1 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
n=16 Participants
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE) (Part 1)
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks (Part 1)Population: The analysis population included all participants in Part 1 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
n=16 Participants
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE (Part 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve of MK-8521 From 0 to Infinity (AUC0-∞) After a Single Dose (Part 1)
|
48.7 nM•hr
Geometric Coefficient of Variation 16.4
|
163 nM•hr
Geometric Coefficient of Variation 6.37
|
84.4 nM•hr
Geometric Coefficient of Variation 20.3
|
101 nM•hr
Geometric Coefficient of Variation 6.07
|
109 nM•hr
Geometric Coefficient of Variation 25.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Participants Treated With a Single Dose of MK-8521 (Part 1)
|
1.24 nM
Geometric Coefficient of Variation 30.2
|
4.29 nM
Geometric Coefficient of Variation 23.5
|
2.63 nM
Geometric Coefficient of Variation 20.0
|
3.10 nM
Geometric Coefficient of Variation 20.8
|
3.54 nM
Geometric Coefficient of Variation 18.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Time Taken to Reach Cmax (Tmax) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1)
|
14 Hours
Interval 8.0 to 30.0
|
10 Hours
Interval 4.0 to 16.0
|
11 Hours
Interval 10.0 to 16.0
|
12 Hours
Interval 8.0 to 12.0
|
14 Hours
Interval 10.0 to 16.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the plasma to decrease by 50%. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1)
|
13.8 Hours
Geometric Coefficient of Variation 15.5
|
13.7 Hours
Geometric Coefficient of Variation 8.93
|
14.8 Hours
Geometric Coefficient of Variation 6.45
|
14.1 Hours
Geometric Coefficient of Variation 2.64
|
13.8 Hours
Geometric Coefficient of Variation 12.9
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through post-trial visit (Up to 7 weeks)Population: The analysis population included all participants in Part 2 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=6 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=8 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) (Part 2)
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 7 weeks (Part 2)Population: The analysis population included all participants in Part 2 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=6 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=8 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE (Part 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Days 1, 5 and 10 (Part 2) (Panels C, D, E)Population: The analysis population included a subset of participants in Part 2 (Panels C, D, and E) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part II, Panel C, D, and E) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel C, D, and E: Days 1, 4, 5, 9, 10 pre-dose; Days 1, 5, 10: 2, 4, 8, 10, 12, 16, 24 hrs. post dose; Day 10: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 1
|
12.0 nM•hr
Geometric Coefficient of Variation 21.3
|
23.1 nM•hr
Geometric Coefficient of Variation 18.9
|
33.5 nM•hr
Geometric Coefficient of Variation 16.4
|
—
|
—
|
—
|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 5
|
22.8 nM•hr
Geometric Coefficient of Variation 20.7
|
43.3 nM•hr
Geometric Coefficient of Variation 23.6
|
60.7 nM•hr
Geometric Coefficient of Variation 19.8
|
—
|
—
|
—
|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 10
|
35.1 nM•hr
Geometric Coefficient of Variation 19.0
|
86.8 nM•hr
Geometric Coefficient of Variation 34.4
|
77.8 nM•hr
Geometric Coefficient of Variation 15.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14 (Part 2) (Panel F)Population: The analysis population included a subset of participants in Part 2 (Panel F) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel F: Days 1, 3, 4, 5, 7, 9, 11, 13, 14 pre-dose; Days 1, 7, 14: 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24 hrs. post-dose; Day 14: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
8.85 nM•hr
Geometric Coefficient of Variation 22.1
|
—
|
—
|
—
|
—
|
—
|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panel F)
Day 7
|
24.8 nM•hr
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
—
|
—
|
|
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
54.6 nM•hr
Geometric Coefficient of Variation 17.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 5 and 10 (Part 2) (Panels C, D, E)Population: The analysis population included participants in Part 2 (Panels C, D, and E) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part 2, Panel C, D, E and F) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel C-E: Days 1, 4, 5, 9, 10 pre-dose; Days 1, 5, 10: 2, 4, 8, 10, 12, 16, 24 hrs. post dose; Day 10: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 1
|
0.642 nM
Geometric Coefficient of Variation 21.8
|
1.25 nM
Geometric Coefficient of Variation 20.0
|
1.85 nM
Geometric Coefficient of Variation 23.1
|
—
|
—
|
—
|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 5
|
1.11 nM
Geometric Coefficient of Variation 22.6
|
2.21 nM
Geometric Coefficient of Variation 23.1
|
3.12 nM
Geometric Coefficient of Variation 16.0
|
—
|
—
|
—
|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 10
|
1.73 nM
Geometric Coefficient of Variation 20.4
|
4.31 nM
Geometric Coefficient of Variation 35.9
|
3.73 nM
Geometric Coefficient of Variation 13.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14 (Part 2) (Panel F)Population: The analysis population included a subset of participants in Part 2 (Panel F) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel F: Days 1, 3, 4, 5, 7, 9, 11, 13, 14 pre-dose; Days 1, 7, 14: 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24 hrs. post-dose; Day 14: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
0.511 nM
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 7
|
1.15 nM
Geometric Coefficient of Variation 22.8
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
2.56 nM
Geometric Coefficient of Variation 19.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 5 and 10 (Part 2) (Panels C, D, E)Population: The analysis population included a subset of participants in Part 2 (Panels C, D, and E) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]). Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part 2, Panel C, D, and E) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected for Part 2, Panel C, D, and E: Days 1, 4, 5, 9, 10 pre-dose; Days 1, 5, 10: 2, 4, 8, 10, 12, 16, 24 hrs. post dose; Day 10: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 1
|
0.493 nM
Geometric Coefficient of Variation 17.6
|
1.00 nM
Geometric Coefficient of Variation 25.0
|
1.33 nM
Geometric Coefficient of Variation 19.6
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 5
|
0.721 nM
Geometric Coefficient of Variation 18.8
|
1.33 nM
Geometric Coefficient of Variation 30.0
|
2.01 nM
Geometric Coefficient of Variation 15.7
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 10
|
1.20 nM
Geometric Coefficient of Variation 14.4
|
2.92 nM
Geometric Coefficient of Variation 40.5
|
2.82 nM
Geometric Coefficient of Variation 17.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14 (Part 2) (Panel F)Population: The analysis population included a subset of participants in Part 2 (Panel F) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]). Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel F: Days 1, 3, 4, 5, 7, 9, 11, 13, 14 pre-dose; Days 1, 7, 14: 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24 hrs. post-dose; Day 14: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
2.09 nM
Geometric Coefficient of Variation 15.3
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
0.498 nM
Geometric Coefficient of Variation 22.8
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 7
|
0.935 nM
Geometric Coefficient of Variation 18.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 5 and 10 (Part 2) (Panels C, D, E)Population: The analysis population included participants in Part 2 (Panels C, D, and E) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part 2, Panel C, D, and E) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel C, D, and E: Days 1, 4, 5, 9, 10 pre-dose; Days 1, 5, 10: 2, 4, 8, 10, 12, 16, 24 hrs. post dose; Day 10: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 1
|
12 Hours
Interval 10.0 to 12.0
|
10 Hours
Interval 8.0 to 24.0
|
10 Hours
Interval 8.0 to 16.0
|
—
|
—
|
—
|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 5
|
9 Hours
Interval 8.0 to 12.0
|
8 Hours
Interval 8.0 to 12.0
|
9 Hours
Interval 4.0 to 12.0
|
—
|
—
|
—
|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 10
|
8 Hours
Interval 8.0 to 10.0
|
10 Hours
Interval 10.0 to 12.0
|
10 Hours
Interval 8.0 to 12.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14 (Part 2) (Panel F)Population: The analysis population included a subset of participants in Part 2 (Panel F) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections occurred at the following time points for Part 2, Panel F: Days 1, 3, 4, 5, 7, 9, 11, 13, 14 pre-dose; Days 1, 7, 14: 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24 hrs. post-dose; Day 14: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
24 Hours
Interval 12.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 7
|
9 Hours
Interval 8.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
10 Hours
Interval 8.0 to 16.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 5 and 10 (Part 2) (Panels C, D, E)Population: The analysis population included a subset of participants in Part 2 (Panels C, D, and E) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the plasma to decrease by 50%. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part 2, Panel C, D, and E) are presented. Method of dispersion is coefficient of variation (%CV). Apparent terminal t1/2 was not reported for certain days since the terminal phase was not adequately captured with sampling up to 24hr post dose. No pharmacokinetic analysis was performed on participants receiving Placebo. Blood was collected for Part 2, Panel C, D, and E: Days 1, 4, 5, 9, 10 pre-dose; Days 1, 5, 10: 2, 4, 8, 10, 12, 16, 24 hrs. post dose; Day 10: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part C, D, and E)
Day 10
|
14.7 Hours
Geometric Coefficient of Variation 17.7
|
15.9 Hours
Geometric Coefficient of Variation 10.9
|
15.5 Hours
Geometric Coefficient of Variation 12.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14 (Part 2) (Panel F)Population: The analysis population included a subset of participants in Part 2 (Panels F) who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the plasma to decrease by 50%. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion is coefficient of variation (%CV). Apparent terminal t1/2 was not reported for certain days since the terminal phase was not adequately captured with sampling up to 24hr post dose. No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections occurred at the following time points for Part 2, Panel F: Days 1, 3, 4, 5, 7, 9, 11, 13, 14 pre-dose; Days 1, 7, 14: 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24 hrs. post-dose; Day 14: 72, 96, 120 hrs. post-dose.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part F)
Day 14
|
16.2 Hours
Geometric Coefficient of Variation 8.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeks (Part 3)Population: The analysis population included all participants in Part 3 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=5 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) (Part 3)
|
5 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeks (Part 3)Population: The analysis population included all participants in Part 3 who received at least one dose of the investigational drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=5 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE (Part 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From -10 to 160 minutes after GGI on Day 1 (Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Pancreatic beta cell sensitivity to ambient glucose concentration after a single dose of MK-8521 125μg/35μg or placebo at Tmax was quantified as the slope of insulin secretion rate relative to glucose concentration (ISR/G) during GGI (160 minutes duration) and assessed against MK-8521 average plasma concentration (Cave) during the GGI to preliminarily characterize the PK/ pharmacodynamic (PD) relationship. Study drug was administered on Day -1. Plasma concentrations of MK-8521 were determined at -10 min pre-GGI and 40, 80, 120 \& 160 min and blood concentrations of glucose, insulin \& C-peptide were determined at -10, -5 (pre-GGI), 20, 40, 60, 80, 100, 120, 140 \& 160 minutes after start of GGI on Day 1 of each period. ISR calculated by deconvolution of C-peptide concentrations using a two-compartmental model was regressed on glucose concentration via simple linear regression; beta cell glucose sensitivity was defined as slope from the regression line.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Average Concentration (Cave) of MK-8521 Corresponding to Slope of Insulin Secretion Rate/Glucose (ISR/G) During Graded Glucose Infusion (GGI) at Tmax After a Single Dose of MK-8521 (Part 3)
|
0.376 nM
Geometric Coefficient of Variation 37.8
|
1.64 nM
Geometric Coefficient of Variation 24.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose), up to 24 hours post-dose on Day 1, up to 24 hours post-dose on Day 2 (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Heart rate was assessed on Day 1 (predose \& 1, 4, 8, 12, 16 \& 24 hrs. postdose) \& Day 2 (36 \& 48 hrs. postdose). Predose and postdose HR were assessed using triplicate and duplicate measurements, respectively. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of HR on Day 1 \& Day 2 of MK-8521 single dosing was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr HR was calculated for each participant where baseline was defined as predose baseline on Day 1.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
n=9 Participants
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hrs (TWA0-24hr) of Heart Rate (HR) After a Single Dose of MK-8521 (Part 1)
Day 2
|
11.77 Beats per minute
Interval 5.78 to 17.76
|
20.91 Beats per minute
Interval 14.18 to 27.64
|
1.69 Beats per minute
Interval -4.7 to 8.07
|
15.43 Beats per minute
Interval 7.22 to 23.65
|
13.73 Beats per minute
Interval 6.9 to 20.55
|
7.76 Beats per minute
Interval 2.56 to 12.95
|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hrs (TWA0-24hr) of Heart Rate (HR) After a Single Dose of MK-8521 (Part 1)
Day 1
|
6.67 Beats per minute
Interval 0.68 to 12.66
|
19.03 Beats per minute
Interval 12.3 to 25.76
|
0.06 Beats per minute
Interval -6.32 to 6.44
|
9.28 Beats per minute
Interval 1.06 to 17.5
|
7.99 Beats per minute
Interval 1.17 to 14.81
|
2.76 Beats per minute
Interval -2.43 to 7.95
|
SECONDARY outcome
Timeframe: Baseline (predose), up to 24 hours post-dose on Day 1, up to 24 hours post-dose on Day 2 (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Systolic blood pressure was assessed on Day 1 (predose and 1, 4, 8, 12, 16 and 24 hrs. postdose) and Day 2 (36 and 48 hrs. postdose). Predose and postdose SBP were assessed using triplicate and duplicate measurements, respectively. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr. of SBP on Day 1 and Day 2 of MK-8521 single dosing was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr SBP was calculated for each participant where baseline was defined as predose baseline on Day 1.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
n=9 Participants
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With A Single Dose of MK-8521 (Part 1)
Day 1
|
-1.09 mmHg
Interval -5.67 to 3.5
|
8.43 mmHg
Interval 3.3 to 13.55
|
-2.24 mmHg
Interval -7.12 to 2.63
|
3.18 mmHg
Interval -3.04 to 9.41
|
0.10 mmHg
Interval -5.1 to 5.3
|
0.78 mmHg
Interval -3.2 to 4.75
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With A Single Dose of MK-8521 (Part 1)
Day 2
|
-2.55 mmHg
Interval -7.14 to 2.03
|
7.81 mmHg
Interval 2.69 to 12.94
|
-0.73 mmHg
Interval -5.61 to 4.15
|
2.03 mmHg
Interval -4.2 to 8.25
|
1.71 mmHg
Interval -3.49 to 6.91
|
1.9 mmHg
Interval -2.08 to 5.87
|
SECONDARY outcome
Timeframe: Baseline (predose), up to 24 hours post-dose on Day 1, up to 24 hours post-dose on Day 2 (Part 1)Population: The analysis population included a subset of participants in Part 1 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Diastolic blood pressure was assessed on Day 1 (predose and 1, 4, 8, 12, 16 \& 24 hrs postdose) and Day 2 (36 and 48 hrs postdose). Predose and postdose DBP were assessed using triplicate and duplicate measurements, respectively. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of DBP on Day 1 and Day 2 of MK-8521 single dosing was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr DBP was calculated for each participant where baseline was defined as predose baseline on Day 1.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=7 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=5 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=3 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
n=5 Participants
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
n=9 Participants
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With A Single Dose of MK-8521 (Part 1)
Day 2
|
-1.41 mmHg
Interval -5.56 to 2.75
|
5.55 mmHg
Interval 0.61 to 10.49
|
-2.56 mmHg
Interval -7.05 to 1.94
|
0.90 mmHg
Interval -5.54 to 7.33
|
2.14 mmHg
Interval -2.8 to 7.08
|
0.57 mmHg
Interval -3.11 to 4.25
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With A Single Dose of MK-8521 (Part 1)
Day 1
|
0.30 mmHg
Interval -3.85 to 4.46
|
5.60 mmHg
Interval 0.66 to 10.54
|
-3.73 mmHg
Interval -8.22 to 0.76
|
-0.80 mmHg
Interval -7.24 to 5.64
|
2.54 mmHg
Interval -2.4 to 7.48
|
-0.07 mmHg
Interval -3.75 to 3.61
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), predose & up to 24 hours postdose on Days 1, 6, and 10Population: The analysis population included a subset of participants in Part 2, Panels C, D, and E who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Heart rate was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs post admission), Day 1 and Day 6 (predose and 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs postdose) and Day 10 (predose \& 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose HR on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 6, and Day 10 HR were assessed using duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of HR on Day 1, Day 6, and Day 10 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs). The change from baseline TWA0-24hr HR was calculated for each participant using TWA0-24hr on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=6 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel C, D, and E)
Day 1
|
1.18 Beats per minute
Interval -3.57 to 5.93
|
0.30 Beats per minute
Interval -4.45 to 5.05
|
4.15 Beats per minute
Interval -0.6 to 8.9
|
-1.91 Beats per minute
Interval -6.66 to 2.84
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel C, D, and E)
Day 6
|
4.24 Beats per minute
Interval -0.51 to 8.99
|
7.96 Beats per minute
Interval 3.21 to 12.71
|
8.52 Beats per minute
Interval 3.77 to 13.27
|
-0.74 Beats per minute
Interval -5.49 to 4.01
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel C, D, and E)
Day 10
|
9.30 Beats per minute
Interval 4.55 to 14.05
|
12.42 Beats per minute
Interval 7.67 to 17.17
|
9.88 Beats per minute
Interval 5.0 to 14.77
|
0.81 Beats per minute
Interval -4.08 to 5.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), predose & up to 24 hours postdose on Days 1, 8, and 14Population: The analysis population included a subset of participants in Part 2, Panel F who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Heart rate was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs post admission), Day 1 \& Day 8 (predose and 2, 4, 6, 8, 12, 16, 24, 36, and 48 hrs. post dose) \& Day 14 (predose and 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose HR on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 8, and Day 14 HR were assessed as duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of HR on Day 1, Day 8, and Day 14 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr. HR was calculated for each participant using TWA0-24hr. on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=2 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
0.14 Beats per minute
Standard Error 1.33
|
0.52 Beats per minute
Standard Error 1.42
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 8
|
5.22 Beats per minute
Standard Error 1.43
|
0.29 Beats per minute
Standard Error 0.66
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Heart Rate (HR) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
9.25 Beats per minute
Standard Error 2.14
|
-1.11 Beats per minute
Standard Error 1.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), predose & up to 24 hours postdose on Days 1, 6, and 10Population: The analysis population included a subset of participants in Part 2, Panels C, D, and E who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Systolic blood pressure was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs. post admission), Day 1 and Day 6 (predose \& 2, 4, 6, 8, 12, 16, 24, 36, and 48 hrs. postdose) and Day 10 (predose \& 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose SBP on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 6, and Day 10 SBP were assessed using duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr SBP on Day 1, Day 6 and Day 10 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs). The change from baseline TWA0-24hr SBP was calculated for each participant using TWA0-24hr on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=6 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 1
|
-0.12 mmHg
Interval -3.87 to 3.63
|
1.57 mmHg
Interval -2.18 to 5.31
|
-2.65 mmHg
Interval -6.4 to 1.09
|
1.19 mmHg
Interval -2.56 to 4.93
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 6
|
-2.08 mmHg
Interval -5.82 to 1.67
|
-2.26 mmHg
Interval -6.0 to 1.49
|
-6.73 mmHg
Interval -10.47 to -2.98
|
-1.18 mmHg
Interval -4.93 to 2.56
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)
Day 10
|
-0.01 mmHg
Interval -3.76 to 3.73
|
-5.78 mmHg
Interval -9.53 to -2.03
|
-2.35 mmHg
Interval -6.3 to 1.6
|
-3.25 mmHg
Interval -7.2 to 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), up to 16 hrs on Day -1, predose & up to 24 hours postdose on Days 1, 8, and 14Population: The analysis population included a subset of participants in Part 2, Panel F who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Systolic blood pressure was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs. post admission), Day 1 and Day 8 (predose and 2, 4, 6, 8, 12, 16, 24, 36, and 48 hrs. post dose) and Day 14 (predose and 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose SBP on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 8, and Day 14 SBP were assessed as duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of SBP on Day 1, Day 8, and Day 14 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr SBP was calculated for each participant using TWA0-24hr on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=2 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
-2.19 mmHg
Standard Error 2.33
|
1.82 mmHg
Standard Error 1.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 8
|
-3.99 mmHg
Standard Error 2.86
|
-6.55 mmHg
Standard Error 0.24
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Systolic Blood Pressure (SBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
-2.25 mmHg
Standard Error 4.15
|
-9.43 mmHg
Standard Error 0.39
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), predose & up to 24 hours postdose on Days 1, 6, and 10Population: The analysis population included a subset of participants in Part 2, Panels C, D, and E who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Diastolic blood pressure was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs. post admission), Day 1 and Day 6 (predose and 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs. postdose) and Day 10 (predose and 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose DBP on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 6, and Day 10 DBP were assessed using duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr. DBP on Day 1, Day 6, and Day 10 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs.). The change from baseline TWA0-24hr DBP was calculated for each participant using TWA0-24hr. on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=6 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=6 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
n=6 Participants
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part C, D, and E)
Day 1
|
1.22 mmHg
Interval -1.87 to 4.3
|
2.38 mmHg
Interval -0.71 to 5.46
|
0.06 mmHg
Interval -3.02 to 3.15
|
0.25 mmHg
Interval -2.83 to 3.33
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part C, D, and E)
Day 6
|
0.37 mmHg
Interval -2.71 to 3.46
|
2.63 mmHg
Interval -0.45 to 5.72
|
-1.22 mmHg
Interval -4.31 to 1.86
|
0.68 mmHg
Interval -2.41 to 3.76
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Part C, D, and E)
Day 10
|
1.58 mmHg
Interval -1.5 to 4.67
|
0.56 mmHg
Interval -2.52 to 3.65
|
3.29 mmHg
Interval 0.09 to 6.5
|
0.53 mmHg
Interval -2.67 to 3.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose; up to 16 hrs on Day -1), predose & up to 24 hours postdose on Days 1, 8, and 14Population: The analysis population included a subset of participants in Part 2, Panel F who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Diastolic blood pressure was assessed on Day -1 (at 2, 4, 6, 8, 12, and 16 hrs. post admission), Day 1 and Day 8 (predose and 2, 4, 6, 8, 12, 16, 24, 36, and 48 hrs. post dose) and Day 14 (predose and 2, 4, 6, 8, 12, 16, and 24 hrs. postdose). Predose DBP on Day 1 was assessed using triplicate measurements while Day -1, Day 1 (postdose), Day 8, and Day 14 DBP were assessed as duplicate measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr of DBP on Day 1, Day 8, Day 14 of MK-8521 multiple dose treatment was calculated as the area under the measurement-time curve divided by the time period of over which the measurements were made (i.e., 24 hrs). The change from baseline TWA0-24hr. DBP was calculated for each participant using TWA0-24hr. on Day -1 as the baseline.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=6 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=2 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 1
|
-0.15 mmHg
Standard Error 1.30
|
1.45 mmHg
Standard Error 1.43
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 8
|
0.41 mmHg
Standard Error 1.54
|
-2.63 mmHg
Standard Error 1.11
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TWA 0-24 Hrs. Semi-recumbent Diastolic Blood Pressure (DBP) of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)
Day 14
|
0.78 mmHg
Standard Error 2.32
|
-3.19 mmHg
Standard Error 0.30
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From -10 to 160 minutes after GGI on Day 1Population: The analysis population included a subset of participants in Part 2, Panel F who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Pancreatic beta cell sensitivity to ambient glucose concentration after a single dose of MK-8521 125μg/35μg or placebo at Tmax was quantified as the slope of insulin secretion rate relative to glucose concentration (ISR/G) during GGI (160 minutes duration). Study drug was administered on Day -1 and blood concentrations of glucose, insulin \& C-peptide were determined at -10, -5 (pre-GGI), 20, 40, 60, 80, 100, 120, 140, and 160 minutes after start of GGI on Day 1 of each period. ISR calculated by deconvolution of C-peptide concentrations using a two compartmental model was regressed on glucose concentration via simple linear regression; beta cell glucose sensitivity was defined as slope from the regression line.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=11 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Slope of Insulin Secretion Rate/Glucose (ISR/G) During Graded Glucose Infusion (GGI) at Tmax After a Single Dose of MK-8521 (Part 3)
|
0.0314 (ng/min.)/(mg/dL)
Interval 0.024 to 0.0412
|
0.0543 (ng/min.)/(mg/dL)
Interval 0.0417 to 0.0706
|
0.0118 (ng/min.)/(mg/dL)
Interval 0.009 to 0.0154
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From -10 to 160 minutes after GGI on Day 1Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Pancreatic beta cell sensitivity to ambient glucose concentration after a single dose of MK-8521 125μg/35μg or placebo at Tmax was quantified as the ratio of the insulin secretion rate to glucose (ISR/G) at the highest glucose infusion rate during GGI (i.e., time weighted average between 120 to 160 minutes \[TWA120-160min\] of ratio \[ISR/G\]). Study drug was administered on Day -1 and blood concentrations of glucose, insulin, and C-peptide were determined at -10, -5 (pre-GGI), 20, 40, 60, 80, 100, 120, 140, and 160 minutes after start of GGI on Day 1 of each period.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=11 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Ratio of ISR/G at the Highest Glucose Infusion Rate During GGI Due to Treatment With A Single Dose of MK-8521 (Part 3)
|
0.0164 (ng/min)/(mg/dL)
Interval 0.0134 to 0.02
|
0.0256 (ng/min)/(mg/dL)
Interval 0.021 to 0.0312
|
0.0084 (ng/min)/(mg/dL)
Interval 0.0069 to 0.0103
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From -10 to 160 minutes after GGI on Day 1Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Glycemic effect during GGI after administration of a single dose of MK 8521 125mcg/35mcg or placebo at Tmax was evaluated as the time-weighted average of glucose concentration throughout the 160 minutes (TWA0-160min) of the GGI. Study drug was administered on Day -1 and blood glucose concentrations were determined at -10, -5 (pre GGI), 20, 40, 60, 80, 100, 120, 140, 160 minutes after start of GGI on Day 1 of each period. The parameter glucose (TWA0-160min) reflects ambient glucose concentration during the GGI.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=11 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Glucose (TWA0-160min) During GGI at Tmax After a Single Dose of MK-8521 (Part 3)
|
118.38 mg/dL
Interval 109.48 to 127.99
|
95.73 mg/dL
Interval 88.84 to 103.16
|
147.94 mg/dL
Interval 136.83 to 159.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From -10 to 160 minutes after GGI on Day 1Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Glycemic effect during GGI after administration of a single dose of MK-8521 125μg/35μg or placebo at Tmax was evaluated as the Gmax during the GGI. Study drug was administered on Day -1 and blood glucose concentrations were determined at -10, -5 (pre-GGI), 20, 40, 60, 80, 100, 120, 140, and 160 minutes after start of GGI on Day 1 of each period. The parameter Gmax reflects ambient glucose concentration during the GGI.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
n=11 Participants
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Maximum Glycemic Excursion (Gmax) During GGI and Tmax After a Single Dose of MK-8521 (Part 3)
|
154.37 mg/dL
Interval 136.5 to 174.48
|
120.43 mg/dL
Interval 107.1 to 135.42
|
217.53 mg/dL
Interval 192.35 to 246.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, -60, -10 min pre-GGI, 40 min, 80 min, 120 min, 160 min, 360 min, and 600 min after start of GGI (Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part III \[35 and 125 μg\]) is presented. Method of dispersion is actually Coefficient of Variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. No pharmacokinetic data was available for AUC0-∞ for Part 3 due to sparse issues during the treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: predose, -60, -10 min pre-GGI, 40 min, 80 min, 120 min, 160 min, 360 min, and 600 min after start of GGI (Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part II, Panel C, D, and E) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. No pharmacokinetic data was available for AUC0-24hr. for Part 3 due to sampling issues during the treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: predose, -60, -10 min pre-GGI, 40 min, 80 min, 120 min, 160 min, 360 min, and 600 min after start of GGI (Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part III \[35 and 125 μg\]) is presented. Method of dispersion is actually Coefficient of Variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Participants Treated With a Single Dose of MK-8521 (Part 3)
|
0.418 nM
Geometric Coefficient of Variation 26.8
|
1.80 nM
Geometric Coefficient of Variation 21.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, -60, -10 min pre-GGI, 40 min, 80 min, 120 min, 160 min, 360 min, and 600 min after start of GGI (Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part III \[35 and 125 μg\]) is presented. No pharmacokinetic analysis was performed on participants receiving Placebo.
Outcome measures
| Measure |
Part 1 Panel A MK-8521 100μg
n=11 Participants
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel A MK-8521 300μg
n=12 Participants
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 150μg
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 175μg
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1 Panel B MK-8521 200μg
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 1, Pooled Placebo
Healthy male participants of 18 to 45 years of age received PBO.
|
|---|---|---|---|---|---|---|
|
Time Taken to Reach Cmax (Tmax) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 3)
|
11.8 Hours
Interval 11.0 to 18.0
|
12.7 Hours
Interval 11.0 to 22.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, -60, -10 min pre-GGI, 40 min, 80 min, 120 min, 160 min, 360 min, and 600 min after start of GGI(Part 3)Population: The analysis population included a subset of participants in Part 3 who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol violations.
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the plasma to decrease by 50%. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part III \[35 and 125 μg\]) is presented. Method of dispersion is actually Coefficient of Variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. No pharmacokinetic data was available for t1/2 for Part 3 due to sampling issues during the treatment period.
Outcome measures
Outcome data not reported
Adverse Events
Part 1, Panel A, MK-8521 100μg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1, Panel A, MK-8521 300μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1, Panel B, MK-8521 150μg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1, Panel B, MK-8521 175μg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, Panel B, MK-8521 200μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2, Panel C, MK-8521 50μg/72μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2, Panel D, MK-8521 100μg/150μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2, Panel E, MK-8521 125μg/150μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2, Panel F, MK-8521 72μg/125μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3, Panel H, MK-8521 35μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3, Panel H, MK-8521 125μg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1, Panel A, MK-8521 100μg
n=7 participants at risk
MK-8521 100μg in healthy male participants of 18 to 45 years of age
|
Part 1, Panel A, MK-8521 300μg
n=5 participants at risk
MK-8521 300μg in healthy male participants of 18 to 45 years of age
|
Part 1, Panel B, MK-8521 150μg
n=6 participants at risk
MK-8521 150μg in healthy male participants of 18 to 45 years of age
|
Part 1, Panel B, MK-8521 175μg
n=3 participants at risk
MK-8521 175μg in healthy male participants of 18 to 45 years of age
|
Part 1, Panel B, MK-8521 200μg
n=5 participants at risk
MK-8521 200μg in healthy male participants of 18 to 45 years of age
|
Part 2, Panel C, MK-8521 50μg/72μg
n=6 participants at risk
MK-8521 50μg Days 1-5 and 72μg Days 6-10 or Placebo in healthy male participants of 18 to 45 years of age
|
Part 2, Panel D, MK-8521 100μg/150μg
n=6 participants at risk
MK-8521 100μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
|
Part 2, Panel E, MK-8521 125μg/150μg
n=6 participants at risk
MK-8521 125μg Days 1-5 and 150μg Days 6-10 in healthy male participants of 18 to 45 years of age
|
Part 2, Panel F, MK-8521 72μg/125μg
n=6 participants at risk
MK-8521 72μg Days 1-7 and 125μg Days 8-14 in obese male participants of 45 to 65 years of age
|
Part 3, Panel H, MK-8521 35μg
n=11 participants at risk
MK-8521 35μg in healthy male participants of 18 to 45 years of age
|
Part 3, Panel H, MK-8521 125μg
n=12 participants at risk
MK-8521 125μg in healthy male participants of 18 to 45 years of age
|
Pooled Placebo
n=29 participants at risk
Placebo in healthy male participants of 18 to 45 years of age and obese male participants 45 to 65 years of age
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
9.1%
1/11 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
6.9%
2/29 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
9.1%
1/11 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
80.0%
4/5 • Number of events 4 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
80.0%
4/5 • Number of events 4 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
66.7%
4/6 • Number of events 5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
50.0%
3/6 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
2/12 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
40.0%
2/5 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
60.0%
3/5 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
18.2%
2/11 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Catheter site pain
|
14.3%
1/7 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
18.2%
2/11 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
4/12 • Number of events 4 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
18.2%
2/11 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
6.9%
2/29 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
40.0%
2/5 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
18.2%
2/11 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Injection site haematoma
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Injection site pain
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
50.0%
3/6 • Number of events 4 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
2/12 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
80.0%
4/5 • Number of events 4 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
60.0%
3/5 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
33.3%
2/6 • Number of events 3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
9.1%
1/11 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
6.9%
2/29 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
8.3%
1/12 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
6.9%
2/29 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
20.0%
1/5 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
9.1%
1/11 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
3.4%
1/29 • Number of events 2 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/7 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/3 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/5 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
16.7%
1/6 • Number of events 1 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/6 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/11 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/12 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
0.00%
0/29 • Up to Day 42
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug or placebo.
|
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 The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER