NCT02123290

DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax

A Proof-of-Concept, Open Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Single Doses of DSM265 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-Infection Over a 35-Day-Extended Observation Period

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Plasmodium Falciparum Malaria
• Plasmodium Vivax Malaria

Interventions

Type	Name	Description
DRUG	DSM265 400mg
DRUG	DSM265 xmg	Dose of DSM265 to be determined based on the results of the first cohort
DRUG	DSM265 ymg	Dose of DSM265 to be determined based on the results of the second cohort

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-04-25
• Last updated: 2016-06-22

Locations

1 site across 1 country: Peru