At a glance
ClinicalIndex Comparison Record- ✓Age 18-55 years at informed consent
- ✓Healthy males or non-pregnant, non-lactating healthy females
- ✓Body mass index 18.0-32.0 kg/m² and weight ≥50 kg
- ✓Blood pressure 90-140 mmHg systolic and 50-90 mmHg diastolic; heart rate 45-100 bpm
- ✕Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- ✕Clinically significant cardiovascular, renal, hepatic, respiratory, or gastrointestinal disease; neurological or psychiatric disorder
- ✕Any cardiac abnormalities including QTcF >450 msec, syncope, arrhythmias, or structural cardiac disease
- ✕History of cholecystectomy or gallstones
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-in-Human, Single-Centre, Single Ascending Dose, Multiple Dose and Pilot Food Effect Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating MMV367, Placebo, and 2 other interventions for Malaria,Falciparum. Completed, enrolled 47 participants across 1 site.
Detailed Summary
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated. In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels. In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state. In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days. Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.
Study Details
Timeline
Interventions
Single dose dispersed in sterile water, fasted.
Single Dose dispersed in sterile water, fasted.
Single dose dispersed in sterile water with a high fat meal.
Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.
Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.
Single dose dispersed in sterile water fasted.