First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367

Summary

This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.

In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.

In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.

In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.

Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.

Conditions

• Malaria,Falciparum

Interventions

DRUG

MMV367

Single dose dispersed in sterile water, fasted.

DRUG

Placebo

Single Dose dispersed in sterile water, fasted.

DRUG

MMV367 (Fed 440mg)

Single dose dispersed in sterile water with a high fat meal.

DRUG

MMV367

Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.

DRUG

Placebo

Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.

DRUG

MMV367 (Fasted 440mg)

Single dose dispersed in sterile water fasted.

Sponsors & Collaborators

• Quotient Sciences

  collaborator INDUSTRY

• Swiss BioQuant

  collaborator INDUSTRY

• Banook Group

  collaborator INDUSTRY

• The Doctors Laboratory Ltd

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Medicines for Malaria Venture

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-29

Primary Completion

2023-01-25

Completion

2023-01-25

Countries

• United Kingdom

Study Locations