Phase 1
N=6
Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum
Infections · Vector Borne Diseases · Systemic Inflammatory Response Syndrome · Inflammation · Pathologic Processes
Bottom Line
View on ClinicalTrials.gov: NCT05979207 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Emax — 0.35 Maximum clearance rate (1/hour)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MMV367 3mg (Drug); P. falciparum IBSM infection (Other); MMV367 5mg (Drug); MMV367 10mg (Drug); MMV367 20mg (Drug); MMV367 90mg (Drug); MMV367 1500mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emax |
0.35 | — |
| PRIMARY EC50 |
15 | — |
| PRIMARY MIC |
6.3 | — |
| PRIMARY MPC90 |
54 | — |
| PRIMARY Parasite Killing Achieved Within 48 Hours, PRR48 |
4.75; 3.64; 4.65; 4.75; 1.81; 2.14 | — |
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.
Eligibility Criteria
Inclusion Criteria
1 Healthy adults aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to two weeks following the EOS visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive). BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in metres.
- Completion of the written informed consent process prior to undertaking any trial-related procedure. 4. Must be willing and able to communicate and participate in the whole trial. 5. Agreement to adhere to Lifestyle Considerations (Section 5.3) throughout the trial duration.
- Must be able to provide contact details of a support person (responsible adult) who is aware of the participant's participation in the study and is available to provide assistance if required (for example with contacting the participant in the event that study staff are unable to, or with transporting the participant to and from the study site if required).
Vital signs and ECG parameters 7. Vital signs at screening (measured after 5 min in the supine position):
- Systolic blood pressure (SBP): 90-140 mmHg,
- Diastolic blood pressure (DBP): 40-90 mmHg,
- Heart rate (HR): 40-100 bpm. Note: Symptomatic postural hypotension will be assessed by measuring SBP and DPB in the standing position (see exclusion criterion 10).
- At Screening and pre-inoculation with the malaria challenge agent (Day 0), normal standard mean of triplicate 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine position:
- QTcF: ≤450 msec (males) or ≤470 msec (females),
- QRS: 50-120 msec,
- PR interval: ≤ 210 msec,
- Normal ECG tracing unless the Principal Investigator or delegate considers an ECG tracing abnormality to be not clinically relevant.
Contraception 9. Women of childbearing potential (WOCBP) who anticipate being sexually active with a male during the trial must agree to use a highly effective method of birth control (see below) combined with a barrier contraceptive from the screening visit until 34 days after the last dose of MMV367 (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of MMV367) and have a negative urine pregnancy test result prior to inoculation with the malaria challenge agent on Day 0.
- Highly effective birth control methods include: combined (oestrogen and progestogen containing) oral/intravaginal/transdermal/implantable hormonal contraception associated with inhibition of ovulation, progestogen-only oral/injectable/implantable hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, or sexual abstinence or same sex relationship.
- Female participants who are abstinent (from penile-vaginal intercourse) must agree to start a double method if they start a sexual relationship with a male during the study. Female participants must not be planning in vitro fertilisation within the required contraception period.
Women of non-childbearing potential (WONCBP) are defined as:
- Natural (spontaneous) post-menopausal defined as being amenorrhoeic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level (FSH) >25 IU/L (or at the local laboratory levels for post-menopause).
- Premenopausal with irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy or salpingectomy at least 6 months before screening (as determined by participant medical history).
- Males who have, or may have, female sexual partners of childbearing potential during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or intrauterine device, or stable oral/transdermal/injectable/implantable hormonal contraceptive by the female partne
Data sourced from ClinicalTrials.gov (NCT05979207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.