Trial Outcomes & Findings for A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants (NCT NCT05138653)
NCT ID: NCT05138653
Last Updated: 2024-11-26
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
From the first dose of study drug up to end of follow-up period (Up to 72 days)
Results posted on
2024-11-26
Participant Flow
73 participants took part in the study at 1 investigative site in the United States of America from 18 October 2021 to 23 January 2023.
Healthy participants were enrolled in single ascending dose (Part A: Cohorts 1 \& 2), food effect (Part A: Cohorts 3) \& multiple ascending dose (Part B: Cohorts 1-5) of the study. The data for the 4 sequences in Cohorts 1 and 2 was collected and presented in a pooled manner in the participant flow.
Participant milestones
| Measure |
Part A: Cohort 1: Sequence 1
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 2
Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 3
Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 4
Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 1
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 2
Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 3
Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 4
Participants were randomized to sequence 4 to receive CVL- 354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 3: Fed/Fasted Sequence
Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part A: Cohort 3: Fasted/Fed Sequence
Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part B: Pooled Placebo
Participants received oral dose of placebo matching CVL-354, once daily (QD) from Day 1 up to Day 14 of Cohort 1 to 5 in Part B.
|
Part B: Cohort 1: CVL-354 10 mg
Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1.
|
Part B: Cohort 2: CVL-354 25 mg
Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2.
|
Part B: Cohort 3: CVL-354 50 mg
Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3.
|
Part B: Cohort 4: CVL-354 80 mg
Participants received oral dose of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4.
|
Part B: Cohort 5: CVL-354 85 mg
Participants received oral dose of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (Up to 13 Weeks)
STARTED
|
2
|
4
|
2
|
2
|
3
|
2
|
3
|
2
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Single Ascending Dose (Up to 13 Weeks)
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Single Ascending Dose (Up to 13 Weeks)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Multiple Ascending Dose (Up to 12 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
8
|
6
|
7
|
8
|
8
|
|
Multiple Ascending Dose (Up to 12 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
5
|
6
|
7
|
7
|
|
Multiple Ascending Dose (Up to 12 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1: Sequence 1
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 2
Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 3
Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 4
Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 1
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 2
Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 3
Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 4
Participants were randomized to sequence 4 to receive CVL- 354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 3: Fed/Fasted Sequence
Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part A: Cohort 3: Fasted/Fed Sequence
Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part B: Pooled Placebo
Participants received oral dose of placebo matching CVL-354, once daily (QD) from Day 1 up to Day 14 of Cohort 1 to 5 in Part B.
|
Part B: Cohort 1: CVL-354 10 mg
Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1.
|
Part B: Cohort 2: CVL-354 25 mg
Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2.
|
Part B: Cohort 3: CVL-354 50 mg
Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3.
|
Part B: Cohort 4: CVL-354 80 mg
Participants received oral dose of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4.
|
Part B: Cohort 5: CVL-354 85 mg
Participants received oral dose of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (Up to 13 Weeks)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Single Ascending Dose (Up to 13 Weeks)
Investigator's Discretion
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Single Ascending Dose (Up to 13 Weeks)
Withdrawal of Consent
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Single Ascending Dose (Up to 13 Weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Multiple Ascending Dose (Up to 12 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Multiple Ascending Dose (Up to 12 Weeks)
Withdrawal of Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Multiple Ascending Dose (Up to 12 Weeks)
Disciplinary Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1: Sequence 1
n=2 Participants
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 2
n=4 Participants
Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 3
n=2 Participants
Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 1: Sequence 4
n=2 Participants
Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 1
n=3 Participants
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 2
n=2 Participants
Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 3
n=3 Participants
Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 2: Sequence 4
n=2 Participants
Participants were randomized to sequence 4 to receive CVL- 354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
|
Part A: Cohort 3: Fed/Fasted Sequence
n=4 Participants
Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part A: Cohort 3: Fasted/Fed Sequence
n=3 Participants
Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods.
|
Part B: Pooled Placebo
n=9 Participants
Participants received oral dose of placebo matching CVL-354, QD from Day 1 up to Day 14 of Cohort 1 to 5 in Part B.
|
Part B: Cohort 1: CVL-354 10 mg
n=8 Participants
Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1.
|
Part B: Cohort 2: CVL-354 25 mg
n=6 Participants
Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2.
|
Part B: Cohort 3: CVL-354 50 mg
n=7 Participants
Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3.
|
Part B: Cohort 4: CVL-354 80 mg
n=8 Participants
Participants received oral dose of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4.
|
Part B: Cohort 5: CVL-354 85 mg
n=8 Participants
Participants received oral dose of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
3 Participants
|
9 Participants
n=19 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=4 Participants
|
73 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
|
8 Participants
n=19 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=3 Participants
|
7 Participants
n=4 Participants
|
67 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
|
8 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
7 Participants
n=4 Participants
|
54 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
7 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
38 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
28 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of follow-up period (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 72 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=16 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 Participants
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 Participants
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 Participants
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of follow up period (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohort 3: Number of Participants With TEAEs
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 22 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=7 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohort 3: Number of Participants With Changes in C-SSRS
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of follow up period (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With TEAEs
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in ECG Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of treatment (Up to 31 days)Population: Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Outcome measures
| Measure |
Part A: Cohort 1 and 2: Pooled Placebo
n=9 Participants
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=8 Participants
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 Participants
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=7 Participants
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=8 Participants
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=8 Participants
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Changes in C-SSRS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Part A: Cohorts 1 and 2: Pooled Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 1: CVL-354 0.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 1: CVL-354 1.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 1: CVL-354 5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 1: CVL-354 15 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 2: CVL-354 45 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 2: CVL-354 90 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 2: CVL-354 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 2: CVL-354 200 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 3: Fed State
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 3: Fasted State
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Cohort 1: CVL-354 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 2: CVL-354 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Cohort 3: CVL-354 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Cohort 4: CVL-354 80 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Cohort 5: CVL-354 85 mg
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 |
Part A: Cohorts 1 and 2: Pooled Placebo
n=16 participants at risk
Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A.
|
Part A: Cohort 1: CVL-354 0.5 mg
n=6 participants at risk
Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 1.5 mg
n=6 participants at risk
Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 5 mg
n=6 participants at risk
Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 1: CVL-354 15 mg
n=5 participants at risk
Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 45 mg
n=5 participants at risk
Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 90 mg
n=4 participants at risk
Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 150 mg
n=6 participants at risk
Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 2: CVL-354 200 mg
n=6 participants at risk
Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods.
|
Part A: Cohort 3: Fed State
n=7 participants at risk
Participants received a single oral dose of CVL-354 50 mg under fed state on Day 1 of either Period 1 or Period 2.
|
Part A: Cohort 3: Fasted State
n=7 participants at risk
Participants received a single oral dose of CVL-354 50 mg under fasted state on Day 1 of either Period 1 or Period 2.
|
Part B: Pooled Placebo
n=9 participants at risk
Participants received oral dose of placebo matching CVL-354, QD from Day 1 up to Day 14 of Cohort 1 to 5 in Part B.
|
Part B: Cohort 1: CVL-354 10 mg
n=8 participants at risk
Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1.
|
Part B: Cohort 2: CVL-354 25 mg
n=6 participants at risk
Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2.
|
Part B: Cohort 3: CVL-354 50 mg
n=7 participants at risk
Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3.
|
Part B: Cohort 4: CVL-354 80 mg
n=8 participants at risk
Participants received oral doses of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4.
|
Part B: Cohort 5: CVL-354 85 mg
n=8 participants at risk
Participants received oral doses of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
33.3%
2/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
20.0%
1/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
37.5%
3/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Infections and infestations
Coronavirus disease 2019 (COVID-19)
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
11.1%
1/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Product Issues
Product taste abnormal
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
General disorders
Feeling abnormal
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Infections and infestations
Urethritis chlamydial
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
16.7%
1/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
12.5%
1/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/5 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/4 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
11.1%
1/9 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/6 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
14.3%
1/7 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
0.00%
0/8 • Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60