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Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1)
Sponsor: Novartis Pharmaceuticals
Summary
This is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin in participants with uncomplicated Plasmodium falciparum malaria.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2025-10-10
Completion Date
2026-07-01
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
KAE609 (Cipargamin)
oral KAE609 (Cipargamin)
SoC (Coartem)
SoC (Coartem)
INE963
oral INE963
Locations (13)
Novartis Investigative Site
Banfora, Burkina Faso
Novartis Investigative Site
Nanoro, Burkina Faso
Novartis Investigative Site
Abidjan, Côte d’Ivoire
Novartis Investigative Site
Azaguié, Côte d’Ivoire
Novartis Investigative Site
Lambaréné, Gabon
Novartis Investigative Site
Libreville, Gabon
Novartis Investigative Site
Kintampo, Ghana
Novartis Investigative Site
Navrongo, Ghana
Novartis Investigative Site
Ahero, Kenya
Novartis Investigative Site
Kisumu, Kenya
Novartis Investigative Site
Kigali, Rwanda
Novartis Investigative Site
Kampala, Uganda
Novartis Investigative Site
Tororo, Uganda