Trials / Recruiting
RecruitingNCT05750628
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Patients With Uncomplicated Plasmodium Falciparum Malaria
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 327 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
Detailed description
The purpose of this platform study is to evaluate the parasiticidal effect and potential for cure with different anti-malarial agents administered as monotherapy and/or in combination therapy with other anti-malarial agents in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. Additionally, the safety, tolerability, and pharmacokinetics of these anti-malarial agents will be evaluated for dose selection for future studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INE963 | oral INE963 |
| DRUG | KAE609 (Cipargamin) | oral KAE609 (Cipargamin) |
| DRUG | SoC (Coartem) | SoC (Coartem) |
| DRUG | KLU156 | oral sachet KLU156 (KAF156 + lumefantrine) |
Timeline
- Start date
- 2024-01-23
- Primary completion
- 2026-06-09
- Completion
- 2026-06-23
- First posted
- 2023-03-02
- Last updated
- 2025-07-30
Locations
12 sites across 6 countries: Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya, Uganda
Source: ClinicalTrials.gov record NCT05750628. Inclusion in this directory is not an endorsement.