NCT04250363

Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	PfSPZ Challenge	Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
DRUG	Palcebo	Participants received single oral dose of placebo matched to M5717 capsule on Day 1.
DRUG	M5717 30 mg	Participants received 30 mg single oral dose of M5717 capsule on Day 1.
DRUG	M5717 60 mg	Participants received 60 mg single oral dose of M5717 capsule on Day 1.
DRUG	M5717 80 mg	Participants received 80 mg single oral dose of M5717 capsule on Day 1.
DRUG	M5717 100 mg	Participants received 100 mg single oral dose of M5717 capsule on Day 1.
DRUG	M5717 200 mg	Participants received 200 mg single oral dose of M5717 capsule on Day 1.
DRUG	Placebo	Participants received single oral dose of placebo matched to M5717 capsule on Day 5.
DRUG	M5717 60 mg	Participants received 60 mg single oral dose of M5717 capsule on Day 5.
DRUG	M5717 100 mg	Participants received 100 mg single oral dose of M5717 capsule on Day 5.
DRUG	M5717 200 mg	Participants received 200 mg single oral dose of M5717 capsule on Day 5.

Timeline

• Start date: 2020-02-17
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2020-01-31
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: Netherlands