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).
Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents, written assent and parental/legal authorized representative (LAR) consent must be obtained, in accordance with local regulations.
Able to provide proof of identity to the satisfaction of the Investigator or delegate completing the enrolment process
Able and willing to communicate effectively and comply with all study procedures for the duration of the study (including IM injections, safety assessments, blood sampling, malaria monitoring, follow-up visits)
Living within local jurisdiction of trial site(s) and available for the duration of the trial Demographics and Contraception
Medical Conditions
Positive malaria blood smear microscopy at the Admission visit (Day -1).
Acute febrile illness within 96 hours prior to enrolment or within 96h prior to Day 1.
Serious adverse reaction or clinically significant hypersensitivity to drugs or formulation excipients used in the study: artemether-lumefantrine (Coartem® or generic formulations) and atovaquone (Wellvone®/Mepron® and/or Malarone® or their generics).
Parallel
MMV371
Drug446 mg/2 mL IM LAI
Placebo for MMV371
DrugIM injection
MMV371
Drug669 mg/3 mL IM LAI
MMV371
DrugUp to 1338 mg (2 x 3 mL), IM injection (ventrogluteal region or vastus lateralis)
8
Treatment groupsSee each treatment group below.
Incidence of adverse events over the 24-week study period
The number of AEs, will be presented
Incidence of grade 2 or greater injection site reactions (ISRs) over the 24-week study period
The number of ISRs will be presented
Incidence of clinically significant laboratory, vital signs and ECG abnormalities over the 24-week study period
Count of events will be presented
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Medicines for Malaria Venture
Lead sponsor
Rinda Ubuzima, Rwanda
Collaborator
Swiss BioQuant
Collaborator
Swiss Tropical & Public Health Institute
Collaborator
ACE Research
Collaborator
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