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

A Phase 1, Placebo-Controlled, Double-Blind Study to Examine the Safety, Tolerability, and Pharmacokinetics of 500 mg KD025 Administered Twice Daily in Healthy Male and Post-Menopausal Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Immune System Disorder (Healthy Volunteer)
• Intervention / Treatment: Drug: Placebo; Drug: Belumosudil mesylate

Detailed Description

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
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14202
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KD025; 500 mg KD025 administered orally twice daily (BID) for 28 days	Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: KD025; SAR445761
Placebo Comparator: Placebo; Placebo administered orally BID for 28 days	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events and serious adverse events	Number of participants with adverse events and serious adverse events	Up to approximately 58 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	Cmax maximum plasma concentration determined directly from the concentration time profile	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	tmax, observed time to reach peak plasma concentration	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	Cmin, Minimum or "trough" plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time cprofile	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours)	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	Accumulation ratio, determined as the ratio of Day 28 AUC divided by Day 1 AUC and as the ratio of Day 28 Cmax divided by Day 1 Cmax	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]	t1/2 terminal elimination half-life	Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

Collaborators and Investigators

• Sponsor: Kadmon, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2014
• Primary Completion (Actual): June 7, 2014
• Study Completion (Actual): June 7, 2014

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 14, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Belumosudil
• Other Study ID Numbers: KD025-103; U1111-1290-9655 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org