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

Summary

This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model.

Healthy men and women, aged 18 to 45 years were to be enrolled in 3 study cohorts and to be administered either P218 or placebo twice, 48 hours apart. Subjects in cohorts 2 and 3 were to be inoculated with P. falciparum sporozoites. Enrolment in cohorts was to proceed sequentially, to facilitate review of data by a Safety Review Team (SRT) before proceeding with a subsequent cohort.

In cohort 1, safety and tolerability of P218 was assessed. In cohorts 2 and 3, chemoprotective activity of P218 against malaria infection was assessed, as well as the Influence of time of initiation of the P218 treatment on the protective effect.

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)

Sponsors & Collaborators

• SGS Life Sciences, a division of SGS Belgium NV

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Swiss BioQuant

  collaborator INDUSTRY

• PrimeVigilance Ltd., UK

  collaborator INDUSTRY

• Biologic LLP, UK

  collaborator INDUSTRY

• Sanaria Inc.

  collaborator INDUSTRY

• FGK Representative Service B.V., The Netherlands

  collaborator INDUSTRY

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Cristina Donini, PhD · MMV

• Pieter-Jan Berghmans, MD · SGS Belgium NV

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

2018-11-16

Primary Completion

2019-05-27

Completion

2019-06-03

Countries

• Belgium

Study Locations