Last reviewed · How we verify
A Single Site, Randomized, Double-blind, Placebo-controlled Phase Ib Study, to Evaluate the Chemoprotective Activity of a Single Dose of MMV390048 in a Controlled P. Falciparum Sporozoite Infection Model in Non-immune Healthy Volunteers
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.
Details
| Lead sponsor | Medicines for Malaria Venture |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2018-01 |
| Completion | 2018-12 |
Conditions
- Malaria,Falciparum
Interventions
- MMV390048
Primary outcomes
- Cohort-specific geometric mean time to parasitaemia — Up to 28 days
Defined by a positive thick blood smear (with 2 qualified microscopists detecting 2 unambiguous parasites each) or qPCR (three positive measurements, each at least 12 hours apart and one with parasitaemia greater 100 parasites per mL), or Day 28 if there is no parasitaemia.
Countries
Germany