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DSM265 Prophylaxis of Plasmodium Falciparum Malaria

NCT02562872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-01-14

No results posted yet for this study

Summary

The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.

The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).

Conditions

  • Healthy

Interventions

DRUG

DSM265

DSM265 400 mg single oral dose

DRUG

Placebo

Placebo to match DSM265, single oral dose

BIOLOGICAL

Sporozoites

Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites

BIOLOGICAL

Infective mosquito bite

Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Center for Infectious Disease Research

    collaborator UNKNOWN

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • James G Kublin, MD/MPH · Fred Hutchinson Cancer Research Centre

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
2016-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02562872 on ClinicalTrials.gov