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DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax

NCT02123290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-06-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Asociacion Civil Selva Amazonica

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Alejandro Llanos, Professor · Clínica de la Asociación Civil Selva Amazónica

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02123290 on ClinicalTrials.gov