A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533.

Inclusion Criteria

• Males and females (of childbearing and non-childbearing potential) , between 18 and 55 years of age, inclusive. Women of childbearing potential (WOCBP) must use highly effective methods of birth control (see Inclusion #3).
• Females of non-childbearing potential:
• 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)
• Women of childbearing potential that have or may have male sexual partners during the course of the study must agree to the use of a double method of contraception of a highly effective method of birth control combined with a barrier contraceptive (condom) when appropriate from screening visit to until 60 days after the last dose of IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of IMP. This duration is based on the predicted half-life of IMP, and may be amended once the actual half-life is calculated during this study). Note: Highly effective birth control methods include: combined (oestrogen and progestogen containing) oral/intravaginal/transdermal hormonal contraception associated with inhibition of ovulation, progestogen-only oral/injectable/implantable hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, or sexual abstinence or same sex relationship.
• Male participants who have, or may have female sexual partners during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or condom plus stable insertable (implant or IUD), injectable, transdermal or combination oral contraceptive by the female partner, from the time of informed consent through to 90 days after the last dose of the IMP (covering a full spermatogenesis cycle of 60 days starting after 5 half-lives of last dose of IMP. This duration is based on the predicted half-life of IMP, and may be amended once the actual half-life is calculated during this study).

Abstinent male participants must agree to start a double method if they begin a sexual relationship with a female during the trial, and through to 90 days after the last dose of the IMP. Male participants with female partners that are surgically sterile or post-menopausal (defined as being amenorrhoeic for at least 12 months without an alternative medical cause), or male participants who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception. Male participants must also agree not to donate sperm up to 3 months after dosing with the IMP.

• Total body weight greater than or equal to 50 kg, and body mass index (BMI) between 18 and 32 kg/m2 inclusive.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs after 5 minutes resting in supine position:
• Systolic blood pressure (SBP) - 90-140 mmHg,
• Diastolic blood pressure (DBP) - 40-90 mmHg,
• Heart rate (HR) 40-100 bpm.
• Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges for both males and females: QT ≤ 500 msec, QTcF ≤450 msec, QTcB ≤450 msec, and PR interval ≤210 msec; and normal ECG tracing unless the Principal Investigator or delegate considers an ECG tracing abnormality to be not clinically significant.
• Having given written informed consent prior to undertaking any study-related procedure.
• Available for t