Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

August 18, 2021

Study Completion Date

August 18, 2021

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.

Trial Locations (1)

Unknown

Leiden University Medical Center, Leiden

All Listed Sponsors
lead

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

INDUSTRY

NCT04250363 - Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model | Biotech Hunter | Biotech Hunter