Stopped: Due to a Medicines for Malaria Venture (MMV) strategic business decision
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Crude Adequate Clinical and Parasitological Response (ACPR) for P. Vivax
Timeframe: On Day 14 post-dose
For P. Falciparum: PCR-adjusted Crude Adequate Clinical and Parasitological Response (ACPR)
Timeframe: On Day 14 post-dose