MMV367

This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants:
Screening period of up to 28 days to recruit healthy adult participants.
Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells.
Days 1-3: Daily follow up via phone call or text message.
Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR).
Day 7 PM: Start of confinement within the clinical trial unit.
Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship.
Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration.
Day 11 AM: End of confinement within clinical trial unit.
Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling.
Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of:
Insufficient parasite clearance following IMP dosing
Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367
Participant discontinuation/withdrawal,
Investigator's discretion in the interest of participant safety.
Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.