At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 188 enrolled
Drug / intervention
KAE609 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria.
In Brief
A Phase 2 clinical trial evaluating KAE609 and Coartem for Malaria. Completed, enrolled 188 participants across 9 sites in 5 countries.
Detailed Summary
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesGabon, Ghana, Mali, Rwanda, Uganda
CollaboratorsWellcome Trust
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionNov 2019
TodayJul 2026
First PostedNov 7, 2017
Enrollment StartNov 16, 2017
Primary CompletionNov 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago
Interventions
KAE609drug
Exploration of different doses of KAE609 to establish safety profile.
Coartemdrug
Control Arm