Who is sponsoring NCT02450578?

NCT02450578 is sponsored by Medicines for Malaria Venture.

What condition does NCT02450578 study?

NCT02450578 studies Plasmodium Falciparum, Malaria.

What drugs are being tested in NCT02450578?

Interventions: DSM265 400mg, Placebo to DSM265 400 mg, Plasmodium falciparum sporozoite challenge, Malarone.

What is the status of NCT02450578?

NCT02450578 is currently COMPLETED.

Last reviewed 2021-01-07 · How we verify

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

NCT02450578 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Medicines for Malaria Venture
Phase	Phase 1
Status	COMPLETED
Enrolment	22
Start date	2015-10
Completion	2016-04

Conditions

Plasmodium Falciparum, Malaria

Interventions

DSM265 400mg
Placebo to DSM265 400 mg
Plasmodium falciparum sporozoite challenge
Malarone

Primary outcomes

Infection Rate — Day 0 to Day 28 post-inoculum (daily)
The infection rate is the number (percentage) of subjects in a cohort who became positive for parasitemia. Complete protection = Subjects with pre-patent period equal to 28 days.
Pre-patent Period — Day 0 to Day 28 post-inoculum (daily)
The pre-patent period is defined as the time (days) from inoculation with PfSPZ to first occurrence of a positive TBS. If no positive TBS is seen by Day 28, this variable is set to 28 days. Complete protection = Subjects showing with pre-patent period equal to 28 days.

Countries

Germany