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A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria

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Trial Profile

A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Sep 2021

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At a glance

  • Drugs Cipargamin (Primary) ; Artemether/lumefantrine
  • Indications Falciparum malaria
  • Focus Adverse reactions
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 19 Aug 2021 Cohort 5 (150 mg single cipargamin dose) and an optional sixth cohort in which patients would receive 110 mg or 225 mg single doses, depending on hepatic safety in cohort 5, were added in a protocol amendment made when the trial was ongoing, as per results published in the Clinical Infectious Diseases.
    • 19 Aug 2021 Results assessing efficacy, pharmacokinetics, and resistance marker analysis across a range of cipargamin doses in adults in subSaharan Africa with uncomplicated plasmodium falciparum malaria, published in the Clinical Infectious Diseases.
    • 03 Jul 2021 Results assessing whehter high prevalence of P. falciparum K13 mutations in Rwanda is associated with slow parasite clearance after treatment with artemether-lumefantrine, published in the Journal of Infectious Diseases

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