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
Phase of Trial: Phase I
Latest Information Update: 11 Dec 2018
At a glance
- Drugs M-5717 (Primary)
- Indications Malaria
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors Merck KGaA
- 21 Aug 2018 Planned number of patients changed from 88 to 80.
- 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.