NCT05979207

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum

An Open Label Phase 1b Study to Characterise the Pharmacokinetic/Pharmacodynamic Relationship and Safety of MMV367 in Healthy Adult Participants Experimentally Infected With Blood Stage Plasmodium Falciparum

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 erythrocytes. * 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 parasitaemia 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 parasitaemia 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 (parasitaemia not reduced ≥10-fold by Day 10 compared with peak parasitaemia on Day 8). * Parasite regrowth following IMP dosing (initial parasite clearance is followed by asexual parasite regrowth above 5000 parasites/mL). 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 parasitaemia (at least one negative qPCR result required).

Conditions

• Infections
• Vector Borne Diseases
• Systemic Inflammatory Response Syndrome
• Inflammation
• Pathologic Processes
• Malaria
• Malaria,Falciparum
• Parasitemia
• Parasitic Diseases
• Protozoan Infections
• Antimalarials
• Anti-Infective Agents

Interventions

Type	Name	Description
DRUG	MMV367 3mg	Single dose
OTHER	P. falciparum IBSM infection	Induced Blood Stage Malaria from infected erythrocytes.
DRUG	MMV367 5mg	Single dose
DRUG	MMV367 10mg	Single dose
DRUG	MMV367 20mg	Single dose
DRUG	MMV367 90mg	Single dose
DRUG	MMV367 1500mg	Single dose

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2023-08-07
• Last updated: 2025-12-10
• Results posted: 2025-12-10

Locations

2 sites across 1 country: Australia