Study to Assess Safety and Effectiveness of Anti-malarial Drugs Alone or Combined in Children and Adults With Uncomplicated Plasmodium Falciparum Malaria

What this Trial Is About

Researchers are evaluating how well different anti-malarial drugs work and how safe they are for treating uncomplicated Plasmodium falciparum malaria in adults, adolescents, and children. This study focuses on the parasite-killing effects and potential cure rates of these drugs when given alone or combined with others. It also looks at how the drugs are processed by the body to help decide doses for future studies. Participants will receive one of several treatments, including varying doses of the oral drug INE963, combinations of oral KAE609 Cipargamin with INE963 or KLU156, or the standard of care drug Coartem. The study has multiple parts with patients allocated randomly to different treatment groups. Dosing levels and combinations are tested to compare how effectively they clear the malaria parasite. During the study, participants will have their parasite levels monitored up to 7 days and clinical response assessed by day 29. Blood samples will be taken by day 22 to study drug levels and how the body absorbs and clears the medicines. Safety is monitored through reports of side effects until day 43. The total participation lasts through these assessments to understand treatment impact and tolerability.

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