A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects

Kadmon

Status and phase: Completed; Phase 1

Conditions: Immune System Disorder (Healthy Volunteer)

Treatments: Drug: Placebo; Drug: Belumosudil mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05918588

KD025-102

U1111-1290-9646 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants.

Full description

Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants between the ages of 18 and 55 years, inclusive.
• Female who was 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Cohort 1

Experimental group

Description:

500 mg KD025 or placebo once daily (QD) for 7 days

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Cohort 2

Experimental group

Description:

800 mg KD025 or placebo QD for 7 days

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Cohort 3

Experimental group

Description:

500 mg KD025 or placebo twice daily (BID) for 7 days

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Cohort 4

Experimental group

Description:

1000 mg KD025 or placebo QD for 7 days

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo