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

NCT ID: NCT05918588

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-21

Study Completion Date

2014-03-06

Brief Summary

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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.

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Detailed Description

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

Conditions

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Immune System Disorder (Healthy Volunteer)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

Belumosudil mesylate

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Cohort 2

800 mg KD025 or placebo QD for 7 days

Group Type EXPERIMENTAL

Belumosudil mesylate

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Cohort 3

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

Group Type EXPERIMENTAL

Belumosudil mesylate

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Cohort 4

1000 mg KD025 or placebo QD for 7 days

Group Type EXPERIMENTAL

Belumosudil mesylate

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Interventions

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Belumosudil mesylate

Pharmaceutical form: capsule; Route of administration: oral

Intervention Type DRUG

Placebo

Pharmaceutical form: capsule; Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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KD025 SAR445761

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kadmon, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational site

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1290-9646

Identifier Type: REGISTRY

Identifier Source: secondary_id

KD025-102

Identifier Type: -

Identifier Source: org_study_id

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