Phase 1
N=8
First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367
Malaria,Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT05507970 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Treatment-Emergent Adverse Events (TEAEs) — 1; 4; 5; 1 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MMV367 (Drug); Placebo (Drug); MMV367 (Fed 440mg) (Drug); MMV367 (Fasted 440mg) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Emergent Adverse Events (TEAEs) |
1; 4; 5; 1; 5; 2 | — |
| PRIMARY Number of Clinically Significant Physical Examination Findings |
1; 0; 4; 0; 0; 0 | — |
| PRIMARY Number of Changes From Baseline for Electrocardiograms (ECGs): RR Interval (The R-R Interval is the Distance Between Two Consecutive R Waves.) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry) |
0; 3; 0; 0; 0; 0 | — |
| PRIMARY Number of Clinically Important Changes From Baseline for Respiratory Rate |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Clinically Important Changes in Heart Rate, Supine |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Clinically Important Changes in Heart Rate, Orthostatic |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula) |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula) |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Clinically Important Changes From Baseline for Blood Pressure in mmHg: Supine |
0; 0; 0; 0; 0; 0 | — |
Summary
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.
In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.
In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.
In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.
Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.
Eligibility Criteria
Inclusion Criteria
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study Demographics and Contraception
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements defined in Section 9.4 Baseline characteristics
- Healthy males or non-pregnant, non-lactating healthy females.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg at screening
Exclusion Criteria
- Medical/Surgical History and Mental Health
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Blood pressure (supine) at screening or admission outside the range of 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
- A decrease of SBP (systolic blood Pressure) ≥20 mmHg after 3 min standing and/or a decrease of DBP (diastolic blood Pressure)
≥10 mmHg after 3 min standing, at screening
- History or presence of known structural cardiac abnormalities, family history of long QT (measured from the beginning of the QRS complex to the end of the T-wave) syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise related clinically significant cardiac events. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QT interval changes
- Presence of sinus node dysfunction, clinically significant PR interval prolongation (>210 msec), intermittent second- or third-degree atrioventricular block, complete bundle branch block, sustained cardiac arrhythmias including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles, abnormal T wave morphology which may impact on the QT/QTc assessment, or QTcF >450 msec. Participants with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the sponsor's medical monitor and the investigator
- Participants with a history of cholecystectomy or gall stones
- Participants with conditions that affect their ability to smell or taste (Part 1 only) including, but not limited to mouth ulcers, gum disease, nasal surgery and smell and/or taste disorders (e.g. dysosmia, dysgeusia, respiratory and/or sinus infection or cold) Physical Examination
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening Diagnostic assessments
- Evidence of current SARS-CoV-2 infection (severe acute respiratory syndrome)
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1 of protocol). Participants with Gilbert's Syndrome are not allowed.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission) Prior Study Participation
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- Participants who have previously been adm
Data sourced from ClinicalTrials.gov (NCT05507970). 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.