Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Inclusion Criteria:

• Participants with microscopic confirmation of acute uncomplicated Plasmodiumfalciparum using Giemsa-stained thick and thin film

• P. falciparum parasitemia of 1,000 to 50,000 asexual parasites/microliter of bloodin Part A and P. falciparum parasitemia of >1,000 to <= 150,000 asexualparasites/microliter of blood in Part B

• Axillary temperature >= 37.5 degree Celsius or tympanic temperature >= 38.0 degreeCelsius (use as per Coronavirus disease 2019 (COVID-19) protocols at the site [onlyat Screening]), or history of fever during the previous 24 hours (at leastdocumented verbally)

• The Investigator confirms that each participant agrees to use appropriatecontraception and barriers, if applicable

• Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the Informed Consent Form (ICF) and thisprotocol

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Mixed Plasmodium infections as per thin film microscopy results

• Signs and symptoms of severe malaria according to World Health Organisation (WHO) 2021 criteria (WHO 2021)

• Known liver abnormalities, liver cirrhosis (compensated or decompensated), knownactive or history of hepatitis B or C (testing not required), underlying hepaticinjury or known severe liver disease, known gallbladder or bile duct disease, acuteor chronic pancreatitis, or severe malnutrition

• Known history or evidence of clinically significant disorders such as,cardiovascular, respiratory (including active tuberculosis), hepatic, renal,gastrointestinal, immunological [including known Human ImmunodeficiencyVirus-Acquired Immunodeficiency Syndrome (HIV-AIDS)], neurological (includingauditory), endocrine, infectious, malignancy, psychiatric, history of convulsions,or other abnormality (including head trauma)

• Previous treatment with pyronaridine as part of a combination therapy during thelast 3 months

• Prior antimalarial therapy or antibiotics with antimalarial activity within aminimum of their 5 plasma half-lives (or within 4 weeks of Screening if half-life isunknown)

• Participants taking medications prohibited by the protocol

• Other protocol defined exclusion criteria could apply