First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants

Phase 1 Completed 88 enrolled Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupDouble-blindOther

Summary

The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants following infection with Plasmodium falciparum.

Timeline

Start: 2017-09-15
Primary completion: 2019-06-14
Completion: 2019-06-14

Publications

Results McCarthy JS, Yalkinoglu O, Odedra A, Webster R, Oeuvray C, Tappert A, Bezuidenhout D, Giddins MJ, Dhingra SK, Fidock DA, Marquart L, Webb L, Yin X, Khandelwal A, Bagchus WM. Safety, pharmacokinetics, and antimalarial activity of the novel plasmodium eukaryotic translation elongation factor 2 inhibitor M5717: a first-in-human, randomised, placebo-controlled, double-blind, single ascending dose study and volunteer infection study. Lancet Infect Dis. 2021 Dec;21(12):1713-1724. doi: 10.1016/S1473-3099(21)00252-8. Epub 2021 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CABAMIQUINE	Small molecule	50 mg	Oral
Subject	CABAMIQUINE	Small molecule	100 mg	Oral
Subject	CABAMIQUINE	Small molecule	150 mg	Oral
Subject	CABAMIQUINE	Small molecule	200 mg	Oral
Subject	CABAMIQUINE	Small molecule	400 mg	Oral
Subject	CABAMIQUINE	Small molecule	600 mg	Oral
Subject	CABAMIQUINE	Small molecule	800 mg	Oral
Subject	CABAMIQUINE	Small molecule	1000 mg	Oral
Subject	CABAMIQUINE	Small molecule	1250 mg	Oral
Subject	CABAMIQUINE	Small molecule	1800 mg	Oral
Subject	CABAMIQUINE	Small molecule	2100 mg	Oral

Indications

No indication recorded.