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).
Age range
18 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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