Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Phase 1 Completed 39 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

RandomizedSequentialDouble-blindPrevention

Summary

The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum sporozoite (PfSPZ) challenge in healthy participants.

Timeline

Start: 2020-02-17
Primary completion: 2021-08-18
Completion: 2021-08-18

Outcome

Met primary endpoint

registry analysis (other test); All Participants: AUC0-24; p = 0.00284; Odds Ratio (OR) 3.57 (95% CI 1.85 to 10.6); Regression, Logistic NCT04250363 ↗

paper A positive dose-exposure-efficacy relationship was established across exposure metrics. PMID 37414066 ↗

Publications

van der Plas JL, Kuiper VP, Bagchus WM, Bodding M, Yalkinoglu O, Tappert A, Seitzinger A, Spangenberg T, Bezuidenhout D, Wilkins J, Oeuvray C, Dhingra SK, Thathy V, Fidock DA, Smidt LCA, Roozen GVT, Koopman JPR, Lamers OAC, Sijtsma J, van Schuijlenburg R, Wessels E, Meij P, Kamerling IMC, Roestenberg M, Khandelwal A. Causal chemoprophylactic activity of cabamiquine against Plasmodium falciparum in a controlled human malaria infection: a randomised, double-blind, placebo-controlled study in the Netherlands. Lancet Infect Dis. 2023 Oct;23(10):1164-1174. doi: 10.1016/S1473-3099(23)00212-8. Epub 2023 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CABAMIQUINE	Small molecule	30 mg	Oral
Subject	CABAMIQUINE	Small molecule	60 mg	Oral
Subject	CABAMIQUINE	Small molecule	80 mg	Oral
Subject	CABAMIQUINE	Small molecule	100 mg	Oral
Subject	CABAMIQUINE	Small molecule	200 mg	Oral

Indications

No indication recorded.