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MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria

NCT02880241 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-12-09

Study results available
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Summary

The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose including pharmacokinetic assessments. The study will investigate descending single doses of MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type. The results of this trial will identify active, well-tolerated doses for investigation in combination with a partner drug within a Phase IIb clinical trial.

Conditions

Interventions

DRUG

MMV390048

Tablets of 20mg each

Sponsors & Collaborators

  • University of Gondar

    collaborator OTHER

  • Jimma University

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Esayas Gudina, MD · Jimma University

  • Mezgebu Silamsaw, MD · University of Gondar

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2018-01-01
Completion
2018-09-24

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02880241 on ClinicalTrials.gov