A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533.

Malaria Clinical Trial

Official title: A Two-part, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single Doses of MMV533, Including a Pilot Food Evaluation in Healthy Participants.

Status Completed

Clinical Trial Summary

Phase 1, single -centre study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics.

Clinical Trial Description

Part 1:

Double-blind, randomized, placebo-controlled, sequential ascending single dose study in healthy adult participants, 7 cohorts, and 1 additional cohort may be considered if needed according to the observed safety, tolerability, and pharmacokinetics results.

A sentinel dosing strategy will be implemented at each dose level to ensure the best conditions of safety. Each cohort will be divided into at least 2 subgroups. The first group (sentinel cohort) will include 2 participants that will be dosed on the first day, with 1 participant receiving MMV533 and 1 participant receiving placebo. The safety and tolerability data from the sentinel cohort up to and including 96 hours post-dose will be reviewed by the Principal Investigator, the Medical Monitor and the Sponsor´s Medical Director. Following a satisfactory safety review, dosing of the remaining participants in the cohort may proceed.

Part 2:

Open label, 2-period cross-over, randomized, pilot food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV533 to healthy male and female participants aged between 18-55 years old. Part 2 may be conducted in parallel to or after completion of Part 1 at the discretion of the SRC. The dose will be selected by the SRC based on PK and safety results obtained in Part 1 and also taking into account the human efficacious dose/exposure predicted from preclinical efficacy studies in rodent malaria models. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT04323306
• Study type: Interventional
• Source: Medicines for Malaria Venture
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2020
• Completion date: September 27, 2022