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Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants

NCT06558643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-05

No results posted yet for this study

Summary

This four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.

For Cohort 1, up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.

For Cohort 2, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.

For Cohort 3, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.

For Cohort 4, if the safety and tolerability results from Cohort 3 are satisfactory, up to 8 participants will be randomly assigned to receive a single dose 1.5 higher than Cohort 3 dose, administered as two IM injections, each at different anatomical locations (one in each deltoid muscle).

Participants' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. When in the clinical unit, the injection site will be checked daily for reactions, and a diary will be provided on discharge for further recording. Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for safety assessments to be performed. Participants are expected to be involved in this study for approximately 12 weeks for all study activities, from screening to the final return visit.

Conditions

  • Malaria,Falciparum

Interventions

DRUG

MMV371 LAI

Single intra-muscular dose

DRUG

Placebo for MMV371

Single intramuscular dose

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • The Doctors Laboratory Ltd

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Nand Singh, MD DPM FFPM · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-09-03
Completion
2025-09-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06558643 on ClinicalTrials.gov