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A Proof-of-concept Study to Assess the Effect of a Range of Doses of Combined Therapy With OZ439 and DSM265 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants

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Trial Profile

A Proof-of-concept Study to Assess the Effect of a Range of Doses of Combined Therapy With OZ439 and DSM265 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Artefenomel (Primary) ; DSM 265 (Primary)
  • Indications Falciparum malaria
  • Focus Pharmacodynamics; Pharmacokinetics; Proof of concept
  • Acronyms OZ/DSMCombo

    • Most Recent Events

    • 28 Jun 2021 Data from 4 studies (OZ439 monotherapy, DSM265 monotherapy;150 mg, DSM265 monotherapy; 400mg, OZ439/DSM265 combination therapy; 200mg of OZ439 combined with 50 and 100mg of DSM265) were used to evaluate efficacy by using within-host model, published in the Journal of Antimicrobial Chemotherapy
    • 04 Nov 2019 Results assessing the safety, pharmacokinetics and pharmacodynamics of artefenomel and DSM265 administered in combination to healthy subjects in a volunteer infection study using the Plasmodium falciparum induced blood stage malaria model published in the Antimicrobial Agents and Chemotherapy
    • 06 Oct 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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