Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda

Summary

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 -1-2 (2 overnight stays), followed by 15 follow-up visits: Day 4, then weekly for 1 month, and subsequently every 2 weeks until the End-of-Study (EoS) visit at Week 24.

These frequent visits are necessary to monitor safety, the levels of MMV371 in the body, and to perform malaria detection testing until EoS (Week 24).

Conditions

• Malaria (Plasmodium Falciparum)
• Malaria Falciparum
• Malaria Infection
• Malaria Prophylaxis
• Malaria Prevention
• Malaria
• Malaria Parasitaemia

Interventions

DRUG

MMV371

446 mg/2 mL IM LAI

DRUG

Placebo for MMV371

IM injection

DRUG

MMV371

669 mg/3 mL IM LAI

DRUG

MMV371

Up to 1338 mg (2 x 3 mL), IM injection (ventrogluteal region or vastus lateralis)

Sponsors & Collaborators

• Rinda Ubuzima, Rwanda

  collaborator UNKNOWN

• Swiss BioQuant

  collaborator INDUSTRY

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• ACE Research

  collaborator UNKNOWN

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Jean-Claude Sumanyi, PMhH · Rinda Ubuzima, Rwanda

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• Rwanda

Study Locations