MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria
Status:
Terminated
Trial end date:
2018-09-24
Target enrollment:
Participant gender:
Summary
The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed
activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced
Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax
malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety
of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose
including pharmacokinetic assessments. The study will investigate descending single doses of
MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type.
The results of this trial will identify active, well-tolerated doses for investigation in
combination with a partner drug within a Phase IIb clinical trial.