Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI… (NCT06558643) | Clinical Trial Compass
CompletedPhase 1
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants
United Kingdom32 participantsStarted 2024-08-27
Plain-language summary
This four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.
For Cohort 1, up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 2, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 3, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 4, if the safety and tolerability results from Cohort 3 are satisfactory, up to 8 participants will be randomly assigned to receive a single dose 1.5 higher than Cohort 3 dose, administered as two IM injections, each at different anatomical locations (one in each deltoid muscle).
Participants' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. When in the clinical unit, the injection site will be checked daily for reactions, and a diary will be provided on discharge for further recording. Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for safety assessments to be performed. Participants are expected to be involved in this study for approximately 12 weeks for all study activities, from screening to the final return visit.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Must provide written informed consent
✓. Must be willing and able to communicate and participate in the whole study Aged 18 to 64 years inclusive at the time of signing informed consent
Exclusion criteria
✕. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients, Wellvone®/Mepron® and/or Malarone®
✕. 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 (BP; supine) at screening or pre-dose outside the range of 90 to 140 mmHg systolic BP in participants ≤45 years, 90 to 150 mmHg SBP in participants \>45 years or 50 to 90 mmHg diastolic BP; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
✕. History or presence of known structural cardiac abnormalities, family history of long QT 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
What they're measuring
1
Number of participants with adverse events (AEs) as assessed by the investigators.
Timeframe: Screening/Day-28 up to 30 days after end of study (EOS) visit.
✕. Presence of sinus node dysfunction, clinically significant PR interval prolongation (\>220 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 a history of cholecystectomy or gall stones.
✕. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening