CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 39 enrolled
Drug / intervention
PfSPZ Challenge +10 morebiological
Likely dose
M5717 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04250363
NCT04250363Phase 1Completed
CompareCT.gov

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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Jan 31, 2020·Updated May 1, 2024

In Brief

A Phase 1 clinical trial evaluating PfSPZ Challenge, Palcebo, and 6 other interventions for Healthy. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 31, 2020
Enrollment StartFeb 17, 2020
Primary CompletionAug 18, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.4 years ago

Interventions

PfSPZ Challengebiological

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

Palcebodrug

Participants received single oral dose of placebo matched to M5717 capsule on Day 1.

M5717 30 mgdrug

Participants received 30 mg single oral dose of M5717 capsule on Day 1.

M5717 60 mgdrug

Participants received 60 mg single oral dose of M5717 capsule on Day 1.

M5717 80 mgdrug

Participants received 80 mg single oral dose of M5717 capsule on Day 1.

M5717 100 mgdrug

Participants received 100 mg single oral dose of M5717 capsule on Day 1.

M5717 200 mgdrug

Participants received 200 mg single oral dose of M5717 capsule on Day 1.

Placebodrug

Participants received single oral dose of placebo matched to M5717 capsule on Day 5.

M5717 60 mgdrug

Participants received 60 mg single oral dose of M5717 capsule on Day 5.

M5717 100 mgdrug

Participants received 100 mg single oral dose of M5717 capsule on Day 5.

M5717 200 mgdrug

Participants received 200 mg single oral dose of M5717 capsule on Day 5.