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DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria

NCT02450578 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-01-13

Study results available
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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.

Conditions

  • Plasmodium Falciparum, Malaria

Interventions

DRUG

DSM265 400mg

DSM265 400mg, single oral administration in a fed state

DRUG

Placebo to DSM265 400 mg

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

BIOLOGICAL

Plasmodium falciparum sporozoite challenge

IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation

DRUG

Malarone

250 mg atovaquone, 100 mg proguanil hydrochloride

Sponsors & Collaborators

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Benjamin Mordmüller, Dr. med · Institut für Tropenmedizin, Uni. of Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450578 on ClinicalTrials.gov