Malaria Clinical Trial
Official title:
A Single Centre, Two-part, Double-blind, Randomized, Placebo-controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of MMV390048 in Healthy Adult Volunteers
This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability
and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when
administered to healthy male volunteers and female volunteers of non-childbearing potential.
In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be
investigated.
The study is a single centre, double-blind, randomised, placebo-controlled, ascending dose
study in healthy male and female volunteers (of non-childbearing potential) aged 18 to 55
years.
The study will be divided into two parts. The first part will comprise up to seven fasted
cohorts (8 to 10 volunteers in each) that will receive a single, ascending dose (SAD) of
MMV390048 to assess its safety, tolerability and pharmacokinetic profile. The starting dose
administered to the first cohort will be 5 mg. An additional cohort (cohort 8, re-using
volunteers from one of the previous cohorts) will receive a single dose of MMV390048 in a fed
state to evaluate the effect of food on the pharmacokinetics and tolerability of the
compound.
The data obtained from each cohort during the SAD part of the study will undergo a formal
review by the Safety Review Team (SRT). Should the safety profile of the compound be deemed
acceptable, and the pharmacokinetic parameters indicate that acceptable levels of the drug to
elicit a pharmacodynamic response can be achieved in human plasma, the study will then
proceed to the second part.
During the second part of the study volunteers will receive multiple, ascending doses (MAD)
of MMV390048 to assess the pharmacokinetics, safety and tolerability following multiple oral
doses. Up to three cohorts of eight volunteers each will be enrolled into this part of the
study. Each volunteer will receive three consecutive daily doses of MMV390048.
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