CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
DSM265 400mg +3 moredrug
Likely dose
DSM265 400mgfrom 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/NCT02450578
NCT02450578Phase 1Completed

Evaluation of the Prophylactic Antimalarial Activity of a Single Dose of DSM265 in Non-immune Healthy Adult Volunteers by Controlled Human Malaria Infection With PfSPZ Challenge

Medicines for Malaria Venture·interventional·Posted May 21, 2015·Updated Jan 13, 2021

In Brief

A Phase 1 clinical trial evaluating DSM265 400mg, Placebo to DSM265 400 mg, and 2 other interventions for Plasmodium Falciparum, Malaria. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 21, 2015
Enrollment StartOct 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.1 years ago

Interventions

DSM265 400mgdrug

DSM265 400mg, single oral administration in a fed state

Placebo to DSM265 400 mgdrug

Placebo to DSM265 400mg, single oral administration in a fed state

Plasmodium falciparum sporozoite challengebiological

IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation

Malaronedrug

250 mg atovaquone, 100 mg proguanil hydrochloride