First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367

This is an interventional treatment trial for Malaria,Falciparum focused on measuring Malaria, Healthy Volunteers Read More

Inclusion Criteria:

1. Must provide written informed consent
2. Must be willing and able to communicate and participate in the whole study Demographics and Contraception
3. Aged 18 to 55 years inclusive at the time of signing informed consent
4. Must agree to adhere to the contraception requirements defined in Section 9.4 Baseline characteristics
5. Healthy males or non-pregnant, non-lactating healthy females.
6. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
7. Weight ≥50 kg at screening

Exclusion Criteria:

• Medical/Surgical History and Mental Health

  1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  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 (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

  5. A decrease of SBP ≥20 mmHg after 3 min standing and/or a decrease of DBP

     ≥10 mmHg after 3 min standing, at screening

  6. 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
  7. 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
  8. Participants with a history of cholecystectomy or gall stones
  9. 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
  10. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening Diagnostic assessments
  11. Evidence of current SARS-CoV-2 infection
  12. 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.
  13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
  14. 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
  15. 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
  16. Participants who have previously been administered IMP in this study. Participants who have taken part in Part 1 are not permitted to take part in Parts 2 and 3 and participants who have taken part in Part 2 are not permitted to take part in Part 3
  17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood Prior and Concomitant Medication
  18. 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, hormonal contraception or HRT) in the 14 days before first IMP administration (see Section 11.4)
  19. Participants who have received a COVID-19 vaccine within 7 days before first IMP administration Lifestyle Characteristics
  20. History of any drug or alcohol abuse in the past 2 years
  21. Regular alcohol consumption in males >21 units per week and 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)
  22. A confirmed positive alcohol breath test at screening or admission
  23. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
  24. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  25. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
  26. Participant with a vegan or vegetarian diet (Part 2 only) Other
  27. Male participants with pregnant or lactating partners

  28. A score of 20 or more on the Beck Depression Inventory (BDI-II), and/or a response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) [7].

      Note, individuals with a BDI-II score of 17-19 may be enrolled, at the discretion of the investigator, if they do not have a medical history of psychiatric conditions and their mental state is not considered to pose additional risk to the health of the individual or to the execution of the trial and interpretation of the data

  29. Participants who are, or are immediate family members of, a study site or sponsor employee
  30. Failure to satisfy the investigator of fitness to participate for any other reason