Conditions: Malaria
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: yes

Brief summary:
A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.

Detailed description:
This was a single center study using blood stage Plasmodium falciparum challenge inoculum to characterize the effectiveness of OZ439 against early blood stage Plasmodium Falciparum infection.

The study was conducted in three cohorts (n=8) using different doses of OZ439. Dose escalation took place after review of the observed OZ439 safety and pharmacodynamic outcome for the previous cohort by the Safety Review Team.

Single doses of 100 mg, 200 mg and 500 mg were administered orally to participants in Cohort 1, Cohort 2 and Cohort 3 respectively.

Arms:
arm 1: OZ439 100mg Powder for Oral Suspension arm 2: OZ439 200mg Powder for Oral Suspension arm 3: OZ439 500mg Powder for Oral Suspension

Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: OZ439 Powder for Oral Suspension

Protocol document: