Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Summary

The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum sporozoite (PfSPZ) challenge in healthy participants.

Conditions

• Healthy

Interventions

BIOLOGICAL

PfSPZ Challenge

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

DRUG

Palcebo

Participants received single oral dose of placebo matched to M5717 capsule on Day 1.

DRUG

M5717 30 mg

Participants received 30 mg single oral dose of M5717 capsule on Day 1.

DRUG

M5717 60 mg

Participants received 60 mg single oral dose of M5717 capsule on Day 1.

DRUG

M5717 80 mg

Participants received 80 mg single oral dose of M5717 capsule on Day 1.

DRUG

M5717 100 mg

Participants received 100 mg single oral dose of M5717 capsule on Day 1.

DRUG

M5717 200 mg

Participants received 200 mg single oral dose of M5717 capsule on Day 1.

DRUG

Placebo

Participants received single oral dose of placebo matched to M5717 capsule on Day 5.

DRUG

M5717 60 mg

Participants received 60 mg single oral dose of M5717 capsule on Day 5.

DRUG

M5717 100 mg

Participants received 100 mg single oral dose of M5717 capsule on Day 5.

DRUG

M5717 200 mg

Participants received 200 mg single oral dose of M5717 capsule on Day 5.

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  lead INDUSTRY

Principal Investigators

• Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-17

Primary Completion

2021-08-18

Completion

2021-08-18

Countries

• Netherlands

Study Locations