A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalating Study to Examine the Safety and Tolerability of Multiple Doses of KD025 (Formerly Called SLX-2119) in Healthy Male and Post- Menopausal Female Subjects
Overview
- Phase
- Phase 1
- Intervention
- Belumosudil mesylate
- Conditions
- Immune System Disorder (Healthy Volunteer)
- Sponsor
- Kadmon, a Sanofi Company
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events and serious adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
500 mg KD025 or placebo once daily (QD) for 7 days
Intervention: Belumosudil mesylate
Cohort 1
500 mg KD025 or placebo once daily (QD) for 7 days
Intervention: Placebo
Cohort 2
800 mg KD025 or placebo QD for 7 days
Intervention: Belumosudil mesylate
Cohort 2
800 mg KD025 or placebo QD for 7 days
Intervention: Placebo
Cohort 3
500 mg KD025 or placebo twice daily (BID) for 7 days
Intervention: Belumosudil mesylate
Cohort 3
500 mg KD025 or placebo twice daily (BID) for 7 days
Intervention: Placebo
Cohort 4
1000 mg KD025 or placebo QD for 7 days
Intervention: Belumosudil mesylate
Cohort 4
1000 mg KD025 or placebo QD for 7 days
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with adverse events and serious adverse events
Time Frame: Up to approximately 37 days
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
Secondary Outcomes
- 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)
- t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7)