Chemoprotective Activity of MMV390048 in PfSPZ Challenge Model
Status:
Withdrawn
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Datamap ICON Clinical Research PrimeVigilance Zagreb PTx Solutions Ltd., UK Sanaria Inc. University of Cape Town