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COMPLETED
NCT07235033
PHASE2

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 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

60

Start Date

2024-01-23

Completion Date

2025-03-19

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DRUG

KAE609

oral capsules administered in combination with KLU156

DRUG

SoC (Coartem)

Standard of Care

DRUG

KLU156

oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)

Locations (3)

Novartis Investigative Site

Abidjan, Côte d’Ivoire

Novartis Investigative Site

Libreville, Gabon

Novartis Investigative Site

Ahero, Kenya