DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of
DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in
adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60
patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax
and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of
parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14
(success criteria for dose de-escalation and continuation of the study).