Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants

Summary

This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.

It is planned to enroll up to 6 sequential cohorts of 8 healthy male participants and healthy female participants of non-childbearing potential in Part A. In Part B, up to 3 sequential cohorts of 8 healthy male participants and healthy non-pregnant, non-lactating female participants will be enrolled. In each cohort, participants will be randomised in a ratio of 6 active investigational medicinal product (IMP) to 2 placebo.

Part A of the study will include two components, Parts A1 and A2. Part A1 includes two initial cohorts, with planned doses of 40 and 100mg, respectively. It is intended to document the human elimination T1/2 of MMV055, which will then be used to shorten the proposed End of Study (EOS) of 48 weeks, if possible.

All cohorts will follow a sentinel dosing design. On Day 1, two sentinel participants (sentinel group) will be randomly assigned to receive a single IM dose of either active IMP or placebo (1 participant each) to assess safety and tolerability (including ISRs).

The sentinel group will be dosed concomitantly at least 7 days prior to the rest of the cohort (main group). The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 5:1 ratio to assess safety and tolerability (including ISRs).

Conditions

• Malaria, Falciparum

Interventions

DRUG

MMV055 Dose 1

40mg

DRUG

MMV055 Dose 2

100mg

DRUG

MMV055 Dose 3

200mg

DRUG

MMV055 Dose 4

400mg

DRUG

MMV055 Dose 5

800mg

DRUG

MMV055 Dose 6

TBCmg

DRUG

Matching placebo Part A

Part A

DRUG

Matching placebo Part B

Part B

COMBINATION_PRODUCT

MMV055/MMV371 Combo 1

Combination 1

COMBINATION_PRODUCT

MMV055/MM371 Combo 2

Combination 2

COMBINATION_PRODUCT

MMV055/MMV371 Combo 3

Combination 3

Sponsors & Collaborators

• Quotient Sciences

  collaborator INDUSTRY

• The Doctors Laboratory Ltd

  collaborator INDUSTRY

• Medicines for Malaria Venture

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2027-12-02

Completion

2027-12-02

Countries

• United Kingdom

Study Locations