NCT07235020

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants 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 Participants With Uncomplicated Plasmodium Falciparum Malaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.

Detailed description

The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).

Conditions

• Uncomplicated Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	INE963	Administered via oral INE963

Timeline

• Start date: 2024-01-23
• Primary completion: 2025-01-30
• Completion: 2025-02-21
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

6 sites across 6 countries: Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya, Uganda