NCT05918588

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2014

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 15, 2023

Last Update Submit

June 15, 2023

Conditions

Immune System Disorder (Healthy Volunteer)

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events and serious adverse events

    Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.

    Up to approximately 37 days

Secondary Outcomes (6)

  • Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

  • tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

  • AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

  • AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

  • Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

  • +1 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: Belumosudil mesylateDrug: Placebo

Cohort 2

EXPERIMENTAL

800 mg KD025 or placebo QD for 7 days

Drug: Belumosudil mesylateDrug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: Belumosudil mesylateDrug: Placebo

Cohort 4

EXPERIMENTAL

1000 mg KD025 or placebo QD for 7 days

Drug: Belumosudil mesylateDrug: Placebo

Interventions

Belumosudil mesylateDRUG

Pharmaceutical form: capsule; Route of administration: oral

Also known as: KD025, SAR445761
Cohort 1Cohort 2Cohort 3Cohort 4
PlaceboDRUG

Pharmaceutical form: capsule; Route of administration: oral

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site

Buffalo, New York, 14202, United States

Location

MeSH Terms

Conditions

Immune System Diseases

Interventions

KD025

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

November 21, 2013

Primary Completion

March 6, 2014

Study Completion

March 6, 2014

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)