Clinical trial NCT05918614: A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Disorder (Healthy Volunteer)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events and serious adverse events
timeFrame: Up to approximately 58 days
Secondary outcomes:
measure: Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
measure: t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
timeFrame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Investigational site
state: New York
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: