First-in-Human Study of MMV367 drug for malaria in healthy participants

The company Medicines for Malaria Venture is commencing recruitment for the clinical trial of the First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367.

The trial officially began on the July 29, 2022 and is planned to complete on December 23, 2022.

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.

Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05507970.