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).
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Adequate Clinical and Parasitological Response rate at Day 14
Timeframe: Day 14
Pharmacokinetic parameter for exposure up to 168 hours
Timeframe: Day 0 to 168 hours post-dose
Pharmacokinetic parameter for exposure AUC (0-t)
Timeframe: Day 0 to Day 28
Area under the plasma concentration vs time curve from time zero to infinity
Timeframe: To Day 28
Maximum plasma concentration (Cmax)
Timeframe: Day 0 to Day 28
Time to reach maximum plasma concentration (tmax)
Timeframe: Day 0 to Day 28
Terminal half-life (t½)
Timeframe: Day 0 to Day 28
The plasma concentration at 168hours post-dose (C168h)
Timeframe: Day 7
The terminal elimination rate constant
Timeframe: Day 0 to 28