A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Ascending Doses of M5717 to Assess the Safety, Tolerability and Pharmacokinetic Profile of Oral Doses, and to Assess the Antimalarial Activity of M5717 Against Plasmodium Falciparum in Healthy Male and Female Adult Subjects

Trial Profile

A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Ascending Doses of M5717 to Assess the Safety, Tolerability and Pharmacokinetic Profile of Oral Doses, and to Assess the Antimalarial Activity of M5717 Against Plasmodium Falciparum in Healthy Male and Female Adult Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Aug 2018

At a glance

  • Drugs M-5717 (Primary)
  • Indications Malaria
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Merck KGaA
  • Most Recent Events

    • 25 Jul 2018 Planned End Date changed from 28 Feb 2019 to 21 Jan 2019.
    • 25 Jul 2018 Planned primary completion date changed from 30 Oct 2018 to 27 Nov 2018.
    • 05 Jun 2018 Planned End Date changed from 31 Jul 2018 to 28 Feb 2019.
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