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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events and serious adverse events
研究概览
简要总结
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.
详细描述
Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1
500 mg KD025 or placebo once daily (QD) for 7 days
干预措施: Belumosudil mesylate (Drug)
Cohort 1
500 mg KD025 or placebo once daily (QD) for 7 days
干预措施: Placebo (Drug)
Cohort 2
800 mg KD025 or placebo QD for 7 days
干预措施: Belumosudil mesylate (Drug)
Cohort 2
800 mg KD025 or placebo QD for 7 days
干预措施: Placebo (Drug)
Cohort 3
500 mg KD025 or placebo twice daily (BID) for 7 days
干预措施: Belumosudil mesylate (Drug)
Cohort 3
500 mg KD025 or placebo twice daily (BID) for 7 days
干预措施: Placebo (Drug)
Cohort 4
1000 mg KD025 or placebo QD for 7 days
干预措施: Belumosudil mesylate (Drug)
Cohort 4
1000 mg KD025 or placebo QD for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events and serious adverse events
时间窗: Up to approximately 37 days
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
次要结局
- 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)