CompletedPhase 1

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

Australia12 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Known hypersensitivity to artesunate or other artemisinin derivatives, lumefantrine, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
. Any history of anaphylaxis or other severe allergic reactions, or other food or drug allergy that the Investigator considers may impact on participant safety.
. History of convulsion (including drug or vaccine-induced episodes). A medical history of febrile convulsion during childhood (\< 5 years) is not an exclusion criterion.
. Presence of current or suspected uncontrolled chronic diseases that may impact participant safety or interpretation of clinical trial results, such as (but not limited to) cardiac or autoimmune disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, or asthma.
. History of malignancy of any organ system (other than localised basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within five years of screening, regardless of whether there is no evidence of local recurrence or metastases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Emax

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

EC50

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

MIC

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

MPC90

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

Parasite Killing Achieved Within 48 Hours, PRR48

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

Trial details

NCT IDNCT05979207

SponsorMedicines for Malaria Venture

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

Results submitted2024-09-25

View on ClinicalTrials.gov More Infections trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Known hypersensitivity to artesunate or other artemisinin derivatives, lumefantrine, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
. Any history of anaphylaxis or other severe allergic reactions, or other food or drug allergy that the Investigator considers may impact on participant safety.
. History of convulsion (including drug or vaccine-induced episodes). A medical history of febrile convulsion during childhood (\< 5 years) is not an exclusion criterion.
. Presence of current or suspected uncontrolled chronic diseases that may impact participant safety or interpretation of clinical trial results, such as (but not limited to) cardiac or autoimmune disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, or asthma.
. History of malignancy of any organ system (other than localised basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within five years of screening, regardless of whether there is no evidence of local recurrence or metastases.

What they're measuring

Emax

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

EC50

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

MIC

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

MPC90

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)

Parasite Killing Achieved Within 48 Hours, PRR48

Timeframe: Day 8 (IMP dosing) until Day 27 (End of Study)