A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate

Inclusion Criteria

• Black male or female, of Sub-Saharan African origin (defined as participants whose parents are both black and are of Sub-Saharan African origin) aged ≥18 years to ≤45 years at the date of signing informed consent. This inclusion criterion will only be assessed at the screening visit
• Healthy as defined by:
• the absence of clinically significant illness and surgery within four weeks prior to dosing. Participants vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic and metabolic disease
• Participants must agree to use the following contraceptive requirements for the applicable duration:
• Female participants of non-childbearing potential (WNCBP): Defined as either postmenopausal (evidence of menopause based on a combination of amenorrhea for at least one year and increased serum follicle-stimulating hormone (FSH) level [>30 IU/L]), or surgical sterilisation (evidence of hysterectomy and/or bilateral oophorectomy) CONTRACEPTION REQUIRED: None
• Female participants of childbearing potential (WOCBP) who anticipate being sexually active with a male during the trial (from one complete menstrual cycle prior to the first IMP administration until 13 weeks after the last IMP administration):

CONTRACEPTION REQUIRED: Highly effective contraception must start one complete menstrual cycle prior to the first day of dosing and continue until 13 weeks after the last IMP administration. Highly effective contraception methods for WOCBP include:

• combined (i.e. oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
• oral
• intravaginal
• transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation:
• oral
• injectable
• implantable
• intrauterine hormone-releasing system (IUS)
• intrauterine device (IUD)
• bilateral tubal occlusion
• infertile male partner (e.g. vasectomised, permanently sterile following bilateral orchidectomy, or any other documented cause of infertility)
• Female participants of childbearing potential (WOCBP) who agree to remain abstinent for the duration of the trial (from one complete menstrual cycle prior to the first IMP administration until 13 weeks after the last IMP administration):

CONTRACEPTION REQUIRED: Abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Calendar, symptothermal and post-ovulation methods of contraception are not considered to be equivalent to abstinence)

• Male participants, who agree to remain abstinent for the duration of the trial (from first IMP administration until 13 weeks after the last IMP administration): CONTRACEPTION REQUIRED: Abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant) If the situation changes post-dose during the trial, participants must use a condom with or without spermicide.
• Male participants, who anticipate being sexually active during the trial period (from first IMP administration until 13 weeks after the last IMP administration) with a woman who is either a WOCBP, a woman who is pregnant and/or breast feeding:

CONTRACEPTION REQUIRED: From the first day of