Conditions: Cure Rate
Keywords: parasitemia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose arm 2: 6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose arm 3: 6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose arm 4: 6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose

Interventions: intervention 1: KAE609 intervention 2: KAE609 intervention 3: KAE609 intervention 4: KAE609
Intervention descriptions: intervention 1: KAE609 75mg single dose intervention 2: KAE609 150mg single dose intervention 3: KAE609 225mg single dose intervention 4: KAE609 300mg single dose

Protocol document: