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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
24
DSM265 400 mg single oral dose
Placebo to match DSM265, single oral dose
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Fred Hutchinson Cancer Research Center - Prevention Center
Seattle, Washington, United States
Number of subjects with positive parasitemia
positive parasitemia detected by qRT-PCR
Time frame: 28 days
Time interval between challenge and the first positive parasitemia
Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean \[days\]
Time frame: 28 days
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Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum