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 Plasmodium falciparum using Giemsa-stained thick and thin film
• P. falciparum parasitemia of 1, 000 to 50,000 asexual parasites/microliter of blood in Part A and P. falciparum parasitemia of >1,000 to = 37.5 degree Celsius or tympanic temperature >= 38.0 degree Celsius (use as per Coronavirus disease 2019 (COVID-19) protocols at the site [only at Screening]), or history of fever during the previous 24 hours (at least documented verbally)
• The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol
• 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), known active or history of hepatitis B or C (testing not required), underlying hepatic injury or known severe liver disease, known gallbladder or bile duct disease, acute or 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 Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDS)], neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions, or other abnormality (including head trauma)
• Previous treatment with pyronaridine as part of a combination therapy during the last 3 months
• Prior antimalarial therapy or antibiotics with antimalarial activity within a minimum of their 5 plasma half-lives (or within 4 weeks of Screening if half-life is unknown)
• Participants taking medications prohibited by the protocol
• Other protocol defined exclusion criteria could apply