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Chemoprotective Activity of MMV390048 in PfSPZ Challenge Model

NCT03195387 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-02-05

No results posted yet for this study

Summary

This study follows a First-In-Human dose-escalation study of MMV390048 (5 to 120 mg MMV390048 powder-in-bottle formulation), a formulation bioavailability study to establish suitable tablet formulation, and a two-part dose-escalation (40 to 120 mg of MMV390048) / induced blood stage malaria (ISBM) challenge study with the new tablet formulation. After identification of the predicted efficacious MMV390048 plasma concentrations in the IBSM model, the current study will evaluate the chemoprotective efficacy of MMV390048 in a standardised and validated controlled human malaria infection (CHMI) model using direct venous inoculation (DVI) of aseptic, purified, cryopreserved, vialed P. falciparum sporozoites (PfSPZ Challenge).

Three sequential cohorts of healthy men and women of non-childbearing potential (WONCBP) will be administered the investigational medicinal product (IMP, i.e. MMV390048) under different conditions. This may identify preventative regimens, to be further investigated in a Phase II program. In the first two cohorts, protective administration of the IMP will occur 1 and 7 days before DVI of PfSPZ challenge. The timing of IMP administration and dosage in the last cohort will be determined on the basis of emerging data from the preceding cohorts, but will not exceed 28 days prior to the challenge nor 120 mg MMV390048.

Conditions

  • Malaria,Falciparum

Interventions

DRUG

MMV390048

Each tablet contains 20 mg MMV390048 and the following excipients: tartaric acid powder, copovidone (Plasdone S-630), hypromellose acetate succinate (AquaSolve HPMC-AS MF), croscaramellose sodium (Solutab), microcrystalline cellulose type 102 (Avicel PH-102), magnesium stearate (Ligamed MF-2-V).

Sponsors & Collaborators

  • Datamap

    collaborator INDUSTRY

  • PrimeVigilance Zagreb

    collaborator UNKNOWN

  • ICON Clinical Research

    collaborator INDUSTRY

  • Sanaria Inc.

    collaborator INDUSTRY

  • PTx Solutions Ltd., UK

    collaborator UNKNOWN

  • University of Cape Town

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Benjamin Mordmüller, Dr · Institute of Tropical Medicine / Centre for Clinical Trials, Eberhard Karls University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Germany

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 NCT03195387 on ClinicalTrials.gov