Trial Outcomes & Findings for A Study of LY3463251 in Healthy Participants (NCT NCT03764774)
NCT ID: NCT03764774
Last Updated: 2025-11-04
Results Overview
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
118 participants
Primary outcome timeframe
Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
Results posted on
2025-11-04
Participant Flow
Cohort 4 was terminated early because data from previous cohorts suggested a low probability of achieving competitive weight loss at tolerable doses.
Participant milestones
| Measure |
Placebo Single Dose
Single dose of placebo administered subcutaneously (SC) on Day 1
|
0.01 Milligram (mg) LY3463251 Part A Cohort 1
Single dose of 0.01 mg LY3463251 administered SC on Day 1.
|
0.03 mg LY3463251 Part A Cohort 2
Single dose of 0.03 mg LY3463251 administered SC on Day 1.
|
0.1 mg LY3463251 Part A Cohort 3
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
3 mg LY3463251 Part A Cohort 6
Single dose of 3 mg LY3463251 administered SC on Day 1.
|
10 mg LY3463251 Part A Cohort 7
Single dose of 10 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, once weekly (QW) on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC QW on Days 1 and 8.
6 mg LY3463251 administered SC QW on Days 15 and 22.
9 mg LY3463251 administered SC QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC QW on Days 1 and 8.
9 mg LY3463251 administered SC QW on Days 15 and 22.
15 mg LY3463251 administered SC QW on Days 29 and 36.
24 mg LY3463251 administered SC QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
13
|
10
|
10
|
18
|
3
|
|
Overall Study
COMPLETED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
8
|
8
|
6
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
4
|
11
|
3
|
Reasons for withdrawal
| Measure |
Placebo Single Dose
Single dose of placebo administered subcutaneously (SC) on Day 1
|
0.01 Milligram (mg) LY3463251 Part A Cohort 1
Single dose of 0.01 mg LY3463251 administered SC on Day 1.
|
0.03 mg LY3463251 Part A Cohort 2
Single dose of 0.03 mg LY3463251 administered SC on Day 1.
|
0.1 mg LY3463251 Part A Cohort 3
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
3 mg LY3463251 Part A Cohort 6
Single dose of 3 mg LY3463251 administered SC on Day 1.
|
10 mg LY3463251 Part A Cohort 7
Single dose of 10 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, once weekly (QW) on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC QW on Days 1 and 8.
6 mg LY3463251 administered SC QW on Days 15 and 22.
9 mg LY3463251 administered SC QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC QW on Days 1 and 8.
9 mg LY3463251 administered SC QW on Days 15 and 22.
15 mg LY3463251 administered SC QW on Days 29 and 36.
24 mg LY3463251 administered SC QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
4
|
9
|
0
|
|
Overall Study
Study Termination
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of LY3463251 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo Single Dose
n=16 Participants
Single dose of placebo administered SC on Day 1
|
0.01 Milligram (mg) LY3463251 Part A Cohort 1
n=6 Participants
Single dose of 0.01 mg LY3463251 administered SC on Day 1.
|
0.03 mg LY3463251 Part A Cohort 2
n=6 Participants
Single dose of 0.03 mg LY3463251 administered SC on Day 1.
|
0.1 mg LY3463251 Part A Cohort 3
n=6 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
n=6 Participants
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
n=6 Participants
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
3 mg LY3463251 Part A Cohort 6
n=6 Participants
Single dose of 3 mg LY3463251 administered SC on Day 1.
|
10 mg LY3463251 Part A Cohort 7
n=6 Participants
Single dose of 10 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
n=6 Participants
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
n=13 Participants
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
n=10 Participants
1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
n=10 Participants
3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
n=18 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
n=3 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 13.9 • n=15 Participants
|
47.0 years
STANDARD_DEVIATION 18.1 • n=161 Participants
|
52.2 years
STANDARD_DEVIATION 10.3 • n=100 Participants
|
49.0 years
STANDARD_DEVIATION 15.8 • n=3 Participants
|
41.0 years
STANDARD_DEVIATION 17.4 • n=8 Participants
|
35.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
53.8 years
STANDARD_DEVIATION 2.8 • n=8 Participants
|
43.7 years
STANDARD_DEVIATION 15.3 • n=8 Participants
|
46.9 years
STANDARD_DEVIATION 11.6 • n=68 Participants
|
48.2 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
45.5 years
STANDARD_DEVIATION 9.7 • n=44 Participants
|
47.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 10.8 • n=20 Participants
|
46.48 years
STANDARD_DEVIATION 12.72 • n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=44 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
43 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=68 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=44 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
75 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=68 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=44 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
76 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=44 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
42 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=44 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
32 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=68 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=44 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
85 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=68 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=44 Participants
|
18 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
118 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)Population: All enrolled participants, whether or not they completed all protocol requirements.
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=6 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
n=6 Participants
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
n=6 Participants
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=16 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=6 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=6 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
n=6 Participants
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
n=6 Participants
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
n=6 Participants
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
n=13 Participants
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
n=10 Participants
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
n=10 Participants
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
n=18 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
n=3 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Event(s) (AEs), All Causalities
|
0 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdosePopulation: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A.
PK: Cmax of LY3463251
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=3 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
n=6 Participants
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
n=6 Participants
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=6 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=6 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=6 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
n=6 Participants
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
n=6 Participants
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A
|
9.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
583 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
1810 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Below quantification level and undetectable, Cmax not calculated.
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Below quantification level and undetectable, Cmax not calculated.
|
16.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
55.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
229 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdosePopulation: All participants who received at least one dose of LY3463251 and had evaluable PK in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78).
PK: Cmax of LY3463251
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=18 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=10 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=10 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=3 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration of LY3463251 Part B
Day 78
|
1190 ng/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
124 ng/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Maximum Observed Concentration of LY3463251 Part B
Day 1
|
150 ng/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
41.7 ng/mL
Geometric Coefficient of Variation 30
|
129 ng/mL
Geometric Coefficient of Variation 19
|
109 ng/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdosePopulation: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A.
PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=6 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
n=6 Participants
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
n=6 Participants
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=6 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=6 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=6 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
n=6 Participants
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
n=6 Participants
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A
|
1470 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 48
|
245000 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
527000 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
|
NA nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Below quantification level and undetectable, AUC\[0-tlast\]) not calculated
|
NA nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Below quantification level and undetectable, AUC\[0-tlast\]) not calculated
|
3010 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
|
15700 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 15
|
75100 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdosePopulation: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78).
PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=18 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=9 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=9 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=2 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B
Day 1
|
20400 ng*h/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
5650 ng*h/mL
Geometric Coefficient of Variation 34
|
18900 ng*h/mL
Geometric Coefficient of Variation 18
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Individual values reported when N = 2: 9810 ng\*h/mL, 13700 ng\*h/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B
Day 78
|
167000 ng*h/mL
Geometric Coefficient of Variation 14
|
—
|
—
|
18000 ng*h/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PD: Day -2; Predose: Day 30 and Day 85 (Part B)Population: All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85).
AUC of glucose was analyzed using a model with treatment + Day + Treatment\*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure.
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
n=9 Participants
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=11 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=9 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=17 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
n=3 Participants
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B
Day -2
|
14.04 millimole*hour per Liter (mmol*h/L)
Standard Deviation 3.01
|
—
|
—
|
14.47 millimole*hour per Liter (mmol*h/L)
Standard Deviation 1.99
|
16.54 millimole*hour per Liter (mmol*h/L)
Standard Deviation 1.95
|
15.52 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.70
|
12.39 millimole*hour per Liter (mmol*h/L)
Standard Deviation 1.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B
Day 30
|
17.12 millimole*hour per Liter (mmol*h/L)
Standard Deviation 3.31
|
—
|
—
|
16.30 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.39
|
17.37 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.47
|
17.33 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.78
|
NA millimole*hour per Liter (mmol*h/L)
Standard Deviation NA
Individual values reported when N=2: 14.73 (3.92) mmol\*h/L; 16.38 ( 2.15) mmol\*h/L
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B
Day 85
|
—
|
—
|
—
|
15.64 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.16
|
15.35 millimole*hour per Liter (mmol*h/L)
Standard Deviation 1.66
|
14.51 millimole*hour per Liter (mmol*h/L)
Standard Deviation 2.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 85 (Part B)Population: All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85).
Change from Baseline in Body Weight
Outcome measures
| Measure |
3/6/9 mg LY3465231 Part B
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
10 mg LY3463251 Part A
10 mg LY3463251 on Day 1.
|
24 mg LY3463251 Part A
24 mg LY3463251 on Day 1.
|
1 mg LY3465231 Part B
n=13 Participants
1 mg LY3465231 SC every week on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B
n=10 Participants
3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
0.1 mg LY3463251 Part A Cohort 3
n=18 Participants
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
|
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
|
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
|
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
|
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8.
6 mg LY3463251 administered SC, QW on Days 15 and 22.
9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
|
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8.
9 mg LY3463251 administered SC, QW on Days 15 and 22.
15 mg LY3463251 administered SC, QW on Days 29 and 36.
24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Day 85 Part B
|
—
|
—
|
—
|
2.11 kilograms (kg)
Standard Deviation 1.80
|
0.77 kilograms (kg)
Standard Deviation 2.66
|
-0.28 kilograms (kg)
Standard Deviation 2.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.01 mg LY3463251
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.03 mg LY3463251
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.1 mg LY3463251
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.3 mg LY3463251
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 mg LY3463251
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3 mg LY3463251
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg LY3463251
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
24 mg LY3463251
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo QW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1 mg LY3463251 QW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 mg LY3463251 QW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3/6/9 mg LY3463251 QW
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
3/9/15/24 mg LY3463251 QW
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo
|
0.01 mg LY3463251
n=6 participants at risk
0.01 mg LY3463251
|
0.03 mg LY3463251
n=6 participants at risk
0.03 mg LY3463251
|
0.1 mg LY3463251
n=6 participants at risk
0.1 mg LY3463251
|
0.3 mg LY3463251
n=6 participants at risk
0.3 mg LY3463251
|
1 mg LY3463251
n=6 participants at risk
1 mg LY3463251
|
3 mg LY3463251
n=6 participants at risk
3 mg LY3463251
|
10 mg LY3463251
n=6 participants at risk
10 mg LY3463251
|
24 mg LY3463251
n=6 participants at risk
24 mg LY3463251
|
Placebo QW
n=13 participants at risk
Placebo QW
|
1 mg LY3463251 QW
n=10 participants at risk
1 mg LY3463251 QW
|
3 mg LY3463251 QW
n=10 participants at risk
3 mg LY3463251 QW
|
3/6/9 mg LY3463251 QW
n=18 participants at risk
3/6/9 mg LY3463251 QW
|
3/9/15/24 mg LY3463251 QW
n=3 participants at risk
3/9/15/24 mg LY3463251 QW
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
3/18 • Number of events 4 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
4/6 • Number of events 4 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
4/6 • Number of events 4 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
55.6%
10/18 • Number of events 14 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
4/6 • Number of events 4 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
4/18 • Number of events 6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Hunger
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Body temperature increased
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
6/18 • Number of events 10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Aura
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
2/3 • Number of events 4 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/5 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
—
0/0 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/2 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
—
0/0 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/18 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60