Trial Outcomes & Findings for First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 (NCT NCT05507970)
NCT ID: NCT05507970
Last Updated: 2025-01-29
Results Overview
Treatment-emergent AEs (TEAEs): AEs that commence during/after the first dose of IMP or commence before first dose of IMP (i.e., a pre-dose AE or existing medical condition) but worsen in intensity during exposure to IMP.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
Received 100mg, 300mg, 750mg or 1500mg placebo oral solution.
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed/Fasted 440mg
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted/Fed 440mg
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
Received 400mg x3 placebo oral solution
Placebo: 1 400mg dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: 100mg
STARTED
|
6
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0
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0
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0
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2
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0
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0
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0
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0
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Part 1: 100mg
COMPLETED
|
6
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0
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0
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0
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2
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0
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0
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0
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0
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Part 1: 100mg
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1: 300mg
STARTED
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0
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6
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0
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0
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2
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Part 1: 300mg
COMPLETED
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0
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6
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0
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0
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2
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0
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0
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0
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0
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Part 1: 300mg
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1: 750mg
STARTED
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0
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0
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6
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0
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1
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0
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0
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0
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0
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Part 1: 750mg
COMPLETED
|
0
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0
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6
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0
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1
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0
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0
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0
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0
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Part 1: 750mg
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1: 1500mg
STARTED
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0
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0
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0
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6
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2
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0
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0
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0
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0
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Part 1: 1500mg
COMPLETED
|
0
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0
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0
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6
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2
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0
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0
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0
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0
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Part 1: 1500mg
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2: 440mg First Intervention (1 Day)
STARTED
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0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: 440mg First Intervention (1 Day)
COMPLETED
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0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: 440mg First Intervention (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2: 440mg Washout (7 Days)
STARTED
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0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: 440mg Washout (7 Days)
COMPLETED
|
0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: 440mg Washout (7 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2: Second Intervention (1 Day)
STARTED
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0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: Second Intervention (1 Day)
COMPLETED
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0
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0
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0
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0
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0
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4
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4
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0
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0
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Part 2: Second Intervention (1 Day)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 3: Multiple Dose Study
STARTED
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0
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0
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0
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0
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0
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0
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0
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6
|
2
|
|
Part 3: Multiple Dose Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
2
|
|
Part 3: Multiple Dose Study
NOT COMPLETED
|
0
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0
|
0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367
Baseline characteristics by cohort
| Measure |
Part 1 Single Ascending Dose Cohort A
n=6 Participants
100mg MMV367 oral solution, fasted. Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B
n=6 Participants
Single ascending dose determined after SAC review of previous cohort.
Intervention: 300mg MMV367 single dose dispersed in sterile water, fasted
|
Part 1 Single Ascending Dose Cohort C
n=6 Participants
Single ascending dose determined after SAC review of previous cohort.
Intervention: 750mg MMV367 single dose dispersed in sterile water, fasted
|
Part 1 Single Ascending Dose Cohort D
n=6 Participants
Single ascending dose determined after SAC review of previous cohort.
Intervention: 1500mg MMV367 single dose dispersed in sterile water, fasted
|
Part 1 Single Ascending Dose Placebo
n=7 Participants
Single ascending dose determined after SAC review of previous cohort.
Intervention: placebo, oral solution, fasted
|
Part 2 Food Effect Fed/Fasted
n=4 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: 440mg dispersed in sterile water in fed and fasted states.
|
Part 2 Food Effect Fasted/Fed
n=4 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
|
Part 3 Multiple Dose 400mg
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 400mg, oral solution, fasted. Once daily for 3 days.
MMV367 400mg: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Placebo
n=2 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: 400mg placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
Placebo: Single dose dispersed in sterile water.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 6.59 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 6.44 • n=4 Participants
|
40.1 years
STANDARD_DEVIATION 10.59 • n=21 Participants
|
37.3 years
STANDARD_DEVIATION 8.88 • n=8 Participants
|
29.3 years
STANDARD_DEVIATION 6.18 • n=8 Participants
|
30.7 years
STANDARD_DEVIATION 11.36 • n=24 Participants
|
39.5 years
STANDARD_DEVIATION 3.54 • n=42 Participants
|
37.2 years
STANDARD_DEVIATION 9.47 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
4 participants
n=8 Participants
|
4 participants
n=8 Participants
|
6 participants
n=24 Participants
|
2 participants
n=42 Participants
|
47 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.Population: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Treatment-emergent AEs (TEAEs): AEs that commence during/after the first dose of IMP or commence before first dose of IMP (i.e., a pre-dose AE or existing medical condition) but worsen in intensity during exposure to IMP.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
1 Number of events
|
4 Number of events
|
5 Number of events
|
1 Number of events
|
5 Number of events
|
2 Number of events
|
1 Number of events
|
12 Number of events
|
12 Number of events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
Severe TEAE
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
IMP-related TEAE
|
0 Number of events
|
0 Number of events
|
2 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
Serious TEAEs
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to participant withdrawal
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to death
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
In the targeted (symptom driven) physical examination, a physician will assess the participant; if the participant reports feeling unwell or has ongoing AEs, then the physician will examine the appropriate body system(s) if required.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Significant Physical Examination Findings
|
1 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
4 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
1 Clinically significant abnormal finding
|
0 Clinically significant abnormal finding
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (individual: Day 1, Pre-dose; mean: Day 1, mean of 3 pre-dose measurements) to any post-dose time point
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Changes From Baseline for Electrocardiograms (ECGs): RR Interval (The R-R Interval is the Distance Between Two Consecutive R Waves.)
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Shifts from within the reference range at baseline to outside the reference range after dosing with IMP.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Creatine kinase 144 hr post dose (144 hr post last dose Part 3)
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Protein follow-up
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Lymphocytes follow-up
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Lymphocytes Pre-dose D3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Lymphocytes 96 hr post last dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
ALT 24 hr
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
ALT 96 hr post last dose
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
ALT end of Study
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Calcium 24 hr post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Calcium follow-up
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Calcium 48 hr post last dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Haematocrit 48 hr post last dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Neutrophils 48 hr post last dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Alkaline phosphatase pre-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Alkaline phosphatase 96 hr post last dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2,and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Important Changes From Baseline for Respiratory Rate
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Important Changes in Heart Rate, Supine
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
PRIMARY outcome
Timeframe: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Important Changes in Heart Rate, Orthostatic
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
PRIMARY outcome
Timeframe: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Systolic Orthostatic Change (mmHg) 6 hr
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
1 Number of clinically important changes
|
0 Number of clinically important changes
|
|
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Diastolic Orthostatic Change (mmHg) 6 hr
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
1 Number of clinically important changes
|
0 Number of clinically important changes
|
|
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Systolic Orthostatic Change (mmHg) 12 hr
|
1 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
|
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Diastolic Orthostatic Change (mmHg) 12 hr
|
1 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
|
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
All other timepoints
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Number of Participants with Out of Range QTcF Values
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Between 450 to 480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Between 480 and 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Prolongation between 30 to 60 msec
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Prolongation greater than 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in totalPopulation: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Number of Participants with Out of Range QTcB Values
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec End of Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec D2 12 hr
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec D3 8 hr
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec D4 36 hr
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
All other timepoints
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 1 hr
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 3 hr
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 5 hr
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 6 hr
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 8 hr
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 12 hr
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 24 hr
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 72 hr
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 96 hr
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec 144 hr
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
QTcB interval increase between 30 to 60 msec Follow-up
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening/day -28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in Part 3). Up to a maximum of 6.5 weeks in total.Population: The data from the fed/fasted and fasted/fed arms are combined and are presented as fed and fasted. No calculations across/between arms were performed.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Outcome measures
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 Participants
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 Participants
Placebo: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 Participants
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 Participants
Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 or placebo, oral solution, fasted. Once daily for 3 days.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Placebo
n=2 Participants
Placebo: 1 dose per day for 3 days, dispersed in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Clinically Important Changes From Baseline for Blood Pressure in mmHg: Supine
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
0 Number of clinically important changes
|
Adverse Events
Part 1 Single Ascending Dose Cohort A 100mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Single Ascending Dose Cohort B 300mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Single Ascending Dose Cohort C 750mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Single Ascending Dose Cohort D 1500mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Food Effect Fed 440mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Food Effect Fasted 440mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 3 Multiple Dose Cohort A 400mgx3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Single Ascending Dose Cohort A 100mg
n=6 participants at risk
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort B 300mg
n=6 participants at risk
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort C 750mg
n=6 participants at risk
MMV367: Single dose dispersed in sterile water.
|
Part 1 Single Ascending Dose Cohort D 1500mg
n=6 participants at risk
MMV367: Single dose dispersed in sterile water.
|
Part 1 Placebo
n=7 participants at risk
Received 100mg, 300mg, 750mg or 1500mg placebo in sterile water.
|
Part 2 Food Effect Fed 440mg
n=8 participants at risk
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 2 Food Effect Fasted 440mg
n=8 participants at risk
Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water.
|
Part 3 Multiple Dose Cohort A 400mgx3
n=6 participants at risk
MMV367 400mg once daily for 3 days in sterile water.
|
Part 3 Placebo
n=2 participants at risk
Received 400mg x3 placebo in sterile water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
14.3%
1/7 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
33.3%
2/6 • Number of events 2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Nervous system disorders
headache
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
12.5%
1/8 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
12.5%
1/8 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
50.0%
1/2 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
50.0%
1/2 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Flatulance
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
14.3%
1/7 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
14.3%
1/7 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
12.5%
1/8 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
14.3%
1/7 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
14.3%
1/7 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Vascular disorders
Orthostatic Hypotension
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
33.3%
2/6 • Number of events 2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Gastrointestinal disorders
Dental parathesia
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/6 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/7 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/8 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
16.7%
1/6 • Number of events 1 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
0.00%
0/2 • AEs will be monitored from the time the participant signs the ICF (Informed Consent Form) until the end of study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and remove information and/or data that may impair the Sponsor's ability to obtain patent protection.
- Publication restrictions are in place
Restriction type: OTHER