At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
KAE609 +1 moredrug
Likely dose
KAE609 75 mgfrom 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 Randomized, Subject and Investigator-blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of KAE609 Administered Intravenously in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating KAE609 and Placebo for Malaria. Completed, enrolled 57 participants across 1 site.
Detailed Summary
This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE609 given in the vein.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesBelgium
CollaboratorsWellcome Trust
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartJul 2020
Primary CompletionNov 2020
TodayJul 2026
First PostedMar 25, 2020
Enrollment StartJul 22, 2020
Primary CompletionNov 10, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.3 years ago
Interventions
KAE609drug
* iv bolus administration over approximately 2 min for doses \< 75 mg (Cohorts A1, A2 and B1) * iv infusion over approximately 10 min for doses ≥ 75 mg (Cohorts A3, A4, A5 and B2)
Placebodrug
matching placeo for iv administration