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

NCT07548021 | Not Yet Recruiting Phase 1

• 1 other identifier: MMV_MMV371_25_01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

malaria prevention; malaria prophylaxis; malaria falciparum; Malaria infection; Malaria Long-Acting Injectable; Long-Acting Injectable

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events over the 24-week study period

  The number of AEs, will be presented

  From signature of informed consent until 30 days after End of Study Visit Day 169 (Week 24)

• Incidence of grade 2 or greater injection site reactions (ISRs) over the 24-week study period

  The number of ISRs will be presented

  From MMV371 admin on day 1 to EOS visit, day 169 (wk 24)

• Incidence of clinically significant laboratory, vital signs and ECG abnormalities over the 24-week study period

  Count of events will be presented

  From informed consent to 30 days post EoS visit wk24 day169

Study Arms (8)

MMV371 446 mg (2 mL) IM in the deltoid

EXPERIMENTAL

Participants will receive a single 2mL IM injection in the deltoid. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: MMV371

Placebo (2 mL) IM in the deltoid

PLACEBO COMPARATOR

Participants will receive a single 2mL IM injection in the deltoid. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: Placebo for MMV371

MMV371 669 mg (3 mL) IM in the ventrogluteal region

EXPERIMENTAL

Participants will receive a single 3mL IM injection in the ventrogluteal region. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: MMV371

Placebo (3 mL) IM in the ventrogluteal region

PLACEBO COMPARATOR

Participants will receive a single 3mL IM injection in the ventrogluteal region. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: Placebo for MMV371

MMV371 669 (3 mL) IM in the vastus lateralis

EXPERIMENTAL

Participants will receive a single 3mL IM injection in the vastus lateralis. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: MMV371

Placebo (3 mL) IM in the vastus lateralis

PLACEBO COMPARATOR

Participants will receive a single 3mL IM injection in the vastus lateralis. Participants will be randomized at a 1:1:1 ratio to the three parallel arms, each corresponding to a specific dose and injection site, and within each arm will receive MMV371 or placebo in a 3:1 ratio.

Drug: Placebo for MMV371

Optional arm MMV371 dose and location TBD

EXPERIMENTAL

If Arm 4 is initiated after SDRT recommendation, participants will be randomized via the IRT system to receive MMV371 or placebo in a 3:1 ratio (MMV371:placebo). The highest dose proposed for Arm 4 will not exceed 1338 mg (6mL given into two separate injections of 3 mL each in the ventrogluteal region or vastus lateralis).

Drug: MMV371

Optional arm placebo dose and location TBD

PLACEBO COMPARATOR

If Arm 4 is initiated after SDRT recommendation, participants will be randomized via the IRT system to receive MMV371 or placebo in a 3:1 ratio (MMV371:placebo). The highest dose proposed for Arm 4 will not exceed 1338 mg (6mL given into two separate injections of 3 mL each in the ventrogluteal region or vastus lateralis).

Drug: Placebo for MMV371

Interventions

MMV371 DRUG

446 mg/2 mL IM LAI

MMV371 446 mg (2 mL) IM in the deltoid

Placebo for MMV371 DRUG

IM injection

Optional arm placebo dose and location TBD; Placebo (2 mL) IM in the deltoid; Placebo (3 mL) IM in the vastus lateralis; Placebo (3 mL) IM in the ventrogluteal region

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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:
• For adults (18-50 years): Body Weight ≥45 kg at screening
• For adolescents (12-17 years): body weight ≥35 kg at screening Participant-reported outcomes (PROs)
• 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.

You may not qualify if:

• 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).
• 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.
• Evidence of clinically significant neurologic, cardiac, gastro-intestinal, dermatologic, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, haematological, oncologic, or renal disease, as determined by medical history, physical examination, and/or laboratory evaluations, including urinalysis.
• History of a bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or a history of significant bruising with blood draws.
• Presence of sinus node dysfunction; clinically significant PR interval prolongation (\>220 msec); intermittent second- or third-degree atrioventricular block; complete bundle branch block; sustained cardiac arrhythmias including, but not limited to, atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia except isolated extrasystoles; abnormal T wave morphology that may interfere with QT/QTc assessment; or QTcF \>450 msec (adults and adolescents).
• Physical Examination
• Participants who do not have adequate venous access for multiple venipunctures or cannulation, as assessed by the Investigator or delegate at screening.
• Participants with tattoos, scars or other clinically significant dermatological lesions or conditions overlying the deltoid, gluteal, or vastus lateralis region that, in the opinion of the Investigator, may interfere with injection site assessments.
• Diagnostic Assessments
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab). or human immunodeficiency virus (HIV) 1 and 2 antibody results.
• Prior Study Participation

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• Rinda Ubuzima, Rwanda: collaborator
• Swiss BioQuant: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• ACE Research: collaborator

Study Sites (1)

Rinda Ubuzima

Kigali, Rwanda

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Jean-Claude Sumanyi, PMhH

  Rinda Ubuzima, Rwanda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MMV

CONTACT

+41 022 555 03 00; info@mmv.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)