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COMPLETED
NCT07811882
PHASE2

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

KAE609 (Cipargamin)

oral KAE609 (Cipargamin)

DRUG

SoC (Coartem)

SoC (Coartem)

DRUG

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