Cure Rate Clinical Trial
Official title:
An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients
enrolled in the study.
cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg
single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients
receive 300mg single dose. After approximately every 6 patients in any cohort have been
treated with a given dose and complete the first 15 days, a safety and tolerability data
review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is
required to either escalate to the next dose level or expand a given cohort with an
additional 6 patients in order to obtain more safety data.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment