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A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.

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Trial Profile

A Phase I/Ib Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of DSM265 in Healthy Subjects and to Assess the Antimalarial Activity of DSM265 in Healthy Subjects with an Induced Blood Stage Plasmodium falciparum Infection.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jul 2021

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At a glance

  • Drugs DSM 265 (Primary) ; Mefloquine
  • Indications Malaria
  • Focus First in man; Pharmacodynamics

    • 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
    • 01 Jun 2017 Primary endpoint (Parasite clearance kinetics in healthy subjects following a blood stage infection with P. falciparum.) has not been met as per the results published in The Lancet Infectious Diseases
    • 01 Jun 2017 Results published in The Lancet Infectious Diseases
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