Malaria Clinical Trial
Official title:
An Experimental Study To Characterize the Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection In Healthy Volunteers
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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