A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cure Rate

Intervention / Treatment
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* Drug: KAE609
* Drug: KAE609
* Drug: KAE609
* Drug: KAE609


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 20 to 60 years Presence of mono-infection of P. falciparum Weight between 40 kg to 90 kg Exclusion Criteria: Patients with signs and symptoms of severe/complicated malaria Mixed Plasmodium infection Presence of other serious or chronic clinical condition requiring hospitalization. Severe malnutrition Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose | Drug: KAE609<br>* KAE609 75mg single dose<br>|
| Experimental: Cohort 2<br>6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose | Drug: KAE609<br>* KAE609 150mg single dose<br>|
| Experimental: Cohort 3<br>6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose | Drug: KAE609<br>* KAE609 225mg single dose<br>|
| Experimental: Cohort4<br>6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose | Drug: KAE609<br>* KAE609 300mg single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day Cure Rate | 28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film). | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parasitemia