A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection

Key Inclusion Criteria

• Monoinfection with P. falciparum confirmed by microscopy
• Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
• Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
• Body weight between 40 to 90 kg

Key Exclusion Criteria

• Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
• Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
• Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
• History of antimalarial use within 2 months of screening
• Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
• Long QT syndrome or QTc using Fridericia's formula >430 msec
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
• Hemoglobin level 2 times the upper limit of normal
• Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be 3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
• Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
• Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening