Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda (NCT07548021) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda
Rwanda80 participantsStarted 2026-09
Plain-language 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).
Who can participate
Age range12 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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
✓. Male or female participants aged 12 to 50 years inclusive at the time of signing informed consent/assent.
✓. WOCBP must be non-pregnant and non-lactating, confirmed by a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission, prior to IMP administration. WOCBP must agree to use, at minimum, acceptable contraception methods, as defined by the Clinical Trials Coordination Group (CTCG) guidance, from 21 days prior to study Day 1 through the End-of Study visit (Week 24) (Clinical Trials Coordination Group (CTCG), 2024).
✓
What they're measuring
1
Incidence of adverse events over the 24-week study period
Timeframe: From signature of informed consent until 30 days after End of Study Visit Day 169 (Week 24)
2
Incidence of grade 2 or greater injection site reactions (ISRs) over the 24-week study period
Timeframe: From MMV371 admin on day 1 to EOS visit, day 169 (wk 24)
3
Incidence of clinically significant laboratory, vital signs and ECG abnormalities over the 24-week study period
Timeframe: From informed consent to 30 days post EoS visit wk24 day169
. Post-menopausal participants must have menopause confirmed at screening, defined as a follicle-stimulating hormone (FSH) level ≥ 25.8 mIU/mL Baseline Characteristics
✓. Healthy volunteers, as determined by:
Exclusion criteria
✕. For adults (18-50 years): Body Weight ≥45 kg at screening
✕0. For adolescents (12-17 years): body weight ≥35 kg at screening Participant-reported outcomes (PROs)
✕1. Able to understand and complete participant-reported outcome assessments (e.g., injection-site reaction diary and injection acceptability assessments), either independently or with assistance, in a language and format approved by the Ethics Committee.
✕. 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).
✕. Any history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis prior to enrolment that, in the opinion of the Investigator, has a reasonable risk of recurrence during the trial.
✕. Any current uncontrolled medical or psychiatric condition, or substance abuse problems that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol, may interfere with study assessments, or could jeopardize the safety of the participant.