Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants

Launched by MEDICINES FOR MALARIA VENTURE · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called MMV371 LAI to see how safe it is and how well it is absorbed by the body when given as a single injection. The study involves healthy adults aged 18 to 64, who will be selected based on certain health criteria. Participants will be divided into three groups, with each group receiving either the test medication or a placebo (a dummy treatment) at different doses. Throughout the study, researchers will monitor participants for any side effects and will collect blood and urine samples to understand how the medication is processed by the body.

If you're considering participating, you'll need to be in good health, with no serious allergies or medical conditions that could affect your safety. The entire process will take about 12 weeks, during which time you'll make several visits to the clinical unit for assessments, including daily checks of the injection site. You’ll also keep a diary to record any changes or reactions after you leave the unit. This study is important for developing new treatments for malaria, a serious disease caused by parasites, and your participation could help advance medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must provide written informed consent
• • 2. 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
• • 4. Must agree to adhere to the contraception requirements defined in Section 9.4 of the Protocol 5. Healthy males or non-pregnant, non-lactating healthy females, determined by normal physical examination, safety bloods, urinalysis, ECG and vital sign assessments 6. Body mass index (BMI) of 19.0 to 32.0 kg/m2 as measured at screening 7. Weight ≥50 kg for males and ≥45 kg for females at screening
• Exclusion Criteria:
• • 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients, Wellvone®/Mepron® and/or Malarone®
• • 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
• • 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
• • 4. 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
• • 5. 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
• • 6. 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.
• • 7. Participants with a history of cholecystectomy or gall stones.
• • 8. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• • 9. Participants with tattoos or scars or other significant dermatological conditions overlying the deltoid region which may interfere with injection site assessments, as determined by the investigator or delegate at screening.
• • 10. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Participants with Gilbert's Syndrome are not allowed
• • 11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results.
• • 12. Transaminases (ALT or AST) \>ULN
• • 13. 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).
• • 14. 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
• • 15. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
• • 16. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, up to 800 mg ibuprofen per day, hormonal contraception or HRT) in the 14 days before IMP administration (see Section 11.4). Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study.
• • 17. Participants who are taking, or who have taken, rifampin/rifabutin, tetracycline and indinavir in the 30 days before IMP administration
• • 18. Participants who have had a COVID-19 vaccine within 14 days before dosing.
• • 19. History of any drug or alcohol abuse in the past 2 years
• • 20. Regular alcohol consumption in males \>21 units per week and in females \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
• • 21. A confirmed positive alcohol breath test at screening or admission
• • 22. Current smokers and those who have smoked within the last 12 months
• • 23. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• • 24. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
• • 25. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1) at screening or admission
• • 26. Male participants with pregnant or lactating partners
• • 27. A score of SI 4 to 5 (related to suicidal ideation) or any SB score (related to suicidal behaviour) as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
• • 28. Participants who are, or are immediate family members of, a study site or sponsor employee.
• • 29. Failure to satisfy the investigator of fitness to participate for any other reason.