NCT02562872

DSM265 Prophylaxis of Plasmodium Falciparum Malaria

Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

Cohort 1: * Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites) * Drug administration on Day -3 * 8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in order to proceed to Cohorts 2a and 2b Cohort 2a: * Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites) * Drug administration on Day -X (to be defined following safety and pharmacokinetic data) * 8 subjects: 6 DSM265 400 mg: 2 matching placebo Cohort 2b: * Controlled human malaria infection on Day 0 (infected mosquito bite) * Drug administration on Day -X (to be defined following safety and pharmacokinetic data) * 8 subjects: 6 DSM265 400 mg: 2 matching placebo

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-09-29
• Last updated: 2022-01-14

Locations

1 site across 1 country: United States