Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

May 27, 2019

Study Completion Date

June 3, 2019

Conditions
Malaria
Interventions
DRUG

P218 (1000 mg) Oral Capsules

1000 mg P218 (4 x 250 mg capsules)

DRUG

Placebo Oral Capsules

Placebo capsules matched to the P218 capsules with regard to appearance and taste

DRUG

P218 (100 mg) Oral Capsules

100 mg P218 (2 x 50 mg capsules)

BIOLOGICAL

PfSPZ Challenge

3200 P. falciparum Sporozoites by direct venous inoculation (DVI)

Trial Locations (1)

2060

SGS Belgium NV Clinical Pharmacology Unit, Antwerp

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

SGS Life Sciences, a division of SGS Belgium NV

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Swiss BioQuant

INDUSTRY

collaborator

PrimeVigilance Ltd., UK

INDUSTRY

collaborator

Biologic LLP, UK

INDUSTRY

collaborator

Sanaria Inc.

INDUSTRY

collaborator

FGK Representative Service B.V., The Netherlands

INDUSTRY

lead

Medicines for Malaria Venture

OTHER