* First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 (QSC207031)
Research type
Research Study
Full title
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
IRAS ID
1005344
Contact name
Benoit Bestgen
Contact email
Sponsor organisation
Medicines for Malaria Venture (MMV)
Eudract number
2022-000918-33
ISRCTN Number
ISRCTN17423851
Research summary
The Sponsor is developing the test medicine, MMV367, for the potential treatment of uncomplicated malaria in adults and children. Malaria is a life-threatening infection that is spread to people by mosquitoes. If left untreated, malaria can lead to death. According to the World Health Organization (WHO), an estimated 627,000 people died of malaria in 2020.
This 3-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.
This study will take place at one non-NHS site, enrolling up to 72 male and female volunteers aged between 18 and 55.
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.
Volunteer’s 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 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 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.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/FT/0068
Date of REC Opinion
13 Jun 2022
REC opinion
Further Information Favourable Opinion