A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

Kadmon, a Sanofi Company8 enrolled

Overview

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.

Up to approximately 58 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Immune System Disorder (Healthy Volunteer)

Interventions

Belumosudil mesylateDRUG

Pharmaceutical form: capsule; Route of administration: oral

PlaceboDRUG

Pharmaceutical form: capsule; Route of administration: oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy participants between the ages of 18 and 55 years, inclusive. * Female who is not of reproductive potential. * Able to provide written informed consent prior to the performance of any study specific procedures. * Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive. Exclusion Criteria: * Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations. * Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Locations (1)

Investigational site

Buffalo, New York, United States

Outcomes

Primary Outcomes

Number of participants with adverse events and serious adverse events

Time frame: Up to approximately 58 days