Phase 1 MMV371 LAI Malaria Study in Rwanda
Summary
NIH has registered a Phase 1b clinical trial (NCT07548021) to evaluate MMV371, a long-acting injectable antimalarial, in approximately 80 healthy adult and adolescent participants aged 12-50 years in Rwanda. The randomized, double-blind, placebo-controlled study will assess safety, tolerability, and pharmacokinetics of a single intramuscular injection, with protective efficacy as an exploratory endpoint. Study duration per participant is up to 7 months; enrollment includes 3:1 randomization of MMV371 to placebo.
“This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda.”
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What changed
NIH has registered a new Phase 1b clinical trial for MMV371, a long-acting injectable antimalarial drug candidate, on ClinicalTrials.gov. The trial will enroll approximately 80 healthy participants aged 12 to 50 years at a site in Rwanda, with a 3:1 randomization of active drug to placebo. Participants will receive a single intramuscular injection and be monitored for up to 7 months for safety, tolerability, pharmacokinetics, and exploratory protective efficacy against malaria infection.
Sponsors, clinical investigators, and institutional review boards involved in malaria drug development should note this trial as an additional competitor compound entering Phase 1 evaluation. Sites capable of conducting Phase 1 antimalarial research in Africa may want to assess their readiness for potential future Phase 2/3 trials in this indication area.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda
Phase 1 NCT07548021 Kind: PHASE1 Apr 23, 2026
Abstract
This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants are protected from becoming ill with malaria whilst the MMV371 is still present in their body. The study will enroll approximately 80 healthy male and female participants, aged 12 to 50 years. Before starting the study participants will be given a standard approved course of artemether lumifantrine (AL) to clear any malaria infection they have. Once the AL course has been completed the study drug will be given by injection in the muscle of the upper arm, the side of the thigh, or the hip. Three out of four participants will receive MMV371 and 1 in four participants will receive placebo. Placebo is a dummy medicine. All participants have an equal chance of being assigned to receive the injection in the upper arm, outer thigh or hip. Neither the participants nor the researchers treating the participants will know who received MMV371 or placebo until after the study is completed.
Key study features include:
- Study duration for each participant: up to 7 months
- MMV371 or placebo given: a single intramuscular (IM) injection
- Visit schedule: Participants will remain in-clinic on Days ...
Conditions: Malaria (Plasmodium Falciparum), Malaria Falciparum, Malaria Infection, Malaria Prophylaxis, Malaria Prevention, Malaria, Malaria Parasitaemia
Interventions: MMV371, Placebo for MMV371, MMV371, MMV371
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