First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367
Status:
Recruiting
Trial end date:
2022-12-23
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Banook Group GlaxoSmithKline Quotient Sciences Swiss Bio Quant The Doctors Laboratory