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KAE609

DRUG7 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Cure RateMalariaPlasmodium Falciparum MalariaUncomplicated Plasmodium Falciparum Malaria

Phase 1

Effectiveness of KAE609 in Reducing Asexual & Sexual Blood-stage P.Falciparum Infection & Infectivity to Mosquitos
TerminatedNCT02543086
Novartis PharmaceuticalsPlasmodium Falciparum Malaria
Start: 2015-07-31End: 2015-09-30Updated: 2019-07-23
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
CompletedNCT04321252
Novartis PharmaceuticalsMalaria
Start: 2020-07-22End: 2020-11-10Updated: 2021-12-13

Phase 2

Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
CompletedNCT01524341
Novartis PharmaceuticalsMalaria
Start: 2012-01-31End: 2012-06-30Updated: 2013-05-13
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
CompletedNCT01836458
Novartis PharmaceuticalsMalaria
Start: 2014-01-31End: 2015-03-31Updated: 2016-10-31
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
CompletedNCT01860989
Novartis PharmaceuticalsCure Rate
Start: 2013-07-31End: 2014-08-31Updated: 2015-09-10
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
CompletedNCT03334747
Novartis PharmaceuticalsMalaria
Start: 2017-11-16End: 2019-11-23Updated: 2021-10-11
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
CompletedNCT07235033
Novartis PharmaceuticalsUncomplicated Plasmodium Falciparum Malaria
Start: 2024-01-23End: 2025-03-19Updated: 2026-05-07

Related Papers

First-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending doses clinical study to assess the safety, tolerability, and pharmacokinetics of cipargamin administered intravenously in healthy adults
Antimicrobial Agents and Chemotherapy2024-07-265 citations
Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa.
2021-12-2018 citations
Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated <i>Plasmodium falciparum</i> Malaria
Clinical Infectious Diseases2021-08-1783 citations
Defining the Antimalarial Activity of Cipargamin in Healthy Volunteers Experimentally Infected with Blood-Stage Plasmodium falciparum.
2021-01-2020 citations
Estimation of the <i>In Vivo</i> MIC of Cipargamin in Uncomplicated Plasmodium falciparum Malaria
Antimicrobial Agents and Chemotherapy2016-11-2233 citations
Spiroindolone KAE609 for Falciparum and Vivax Malaria
New England Journal of Medicine2014-07-30244 citations