A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male 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

NCT05918627

U1111-1291-6021 (Other Identifier)

SLx-2119-09-01

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.

Full description

Duration per participants is Day 1 up to 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.
• 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

• Participants are excluded from the study if any of the following criteria apply:
• 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 6 patient groups

Dose level 1

Experimental group

Description:

Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Dose level 2

Experimental group

Description:

Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Dose level 3

Experimental group

Description:

Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Dose level 4

Experimental group

Description:

Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Dose level 5

Experimental group

Description:

Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo

Dose level 6

Experimental group

Description:

Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1

Treatment:

Drug: Belumosudil mesylate

Drug: Placebo