A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KHN702 Tablets in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- The incidence and severity of adverse events (AEs)
研究概览
简要总结
This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs).
详细描述
This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be 7 cohorts in Part 1 and 3 cohorts in Part 2.
The SAD study will enroll approximately 54 HVs across 7 dose cohorts. All participants in Part 1 will be administered with a single oral dose of KHN702 or its matching placebo under fasted condition.
Approximately 30 HVs will be enrolled in the multiple ascending dose study. All participants in Part 2 will received KHN702 or placebo once daily for continuous 7 days (QD x 7d) in a double-blind manner.
The safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KHN702 tablet-Part I
All participants will receive single dose of KHN702 tablet or placebo.
干预措施: KHN702 tablet or placebo (Drug)
KHN702 tablet-Part II
All participants will receive mutiple doses of KHN702 tablet or placebo.
干预措施: KHN702 tablet or placebo (Drug)
结局指标
主要结局
The incidence and severity of adverse events (AEs)
时间窗: From screening to Day 4 for Part 1, and Day 10 for Part 2.
Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.
次要结局
- Area under plasma concentration-time curve from zero to infinity (AUC0-inf)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Apparent total body clearance (CL/F)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Maximum observed plasma concentration (Cmax)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Time to reach maximum observed concentration (Tmax)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Terminal elimination half-life (t1/2)(Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.)
- Area under the plasma concentration-curve across the dosing interval (AUC0-tau)(Day 1 to Day 10.)