Trials / Completed
CompletedNCT03334747
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KAE609 | Exploration of different doses of KAE609 to establish safety profile. |
| DRUG | Coartem | Control Arm |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2019-11-23
- Completion
- 2019-11-23
- First posted
- 2017-11-07
- Last updated
- 2021-10-11
- Results posted
- 2020-09-25
Locations
9 sites across 5 countries: Gabon, Ghana, Mali, Rwanda, Uganda
Source: ClinicalTrials.gov record NCT03334747. Inclusion in this directory is not an endorsement.