NCT05918614已完成1 期
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
Kadmon, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 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 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
详细描述
Up to approximately 58 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
- Parallel
- 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 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.
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
KD025
Experimental
500 mg KD025 administered orally twice daily (BID) for 28 days
干预措施: Belumosudil mesylate (Drug)
Placebo
Placebo Comparator
Placebo administered orally BID for 28 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 58 days
Number of participants with adverse events and serious adverse events
次要结局
- AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
- t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)](Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28)
研究者
研究点 (1)
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