KALUMI - A Phase 2 interventional, multicenter, randomized, openlabel study in three age-descending cohorts to evaluate efficacy, safety and tolerability of KAF156 and Lumefantrine-SDF combination in the treatment of acute uncomplicated Plasmodium falciparum Malar
Project Abstract
This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).