A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HRS-1893 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PK profile of HRS-1893 after a single oral (PO) administration
研究概览
简要总结
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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 white participants;
- •Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- •Male aged between 18 to 55 years of age (inclusive)
- •Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- •Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
排除标准
- •History or evidence of clinically significant disorders
- •History of cardiomyopathy and/or unexplained heart failure
- •Individuals with a history of drug allergies, specific allergies
- •Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
研究组 & 干预措施
HRS-1893 Dose level 2
Single oral high dose of HRS-1893 (dose level 2)
干预措施: HRS-1893 (Drug)
HRS-1893 Dose level 1
Single oral low dose of HRS-1893 (dose level 1)
干预措施: HRS-1893 (Drug)
结局指标
主要结局
PK profile of HRS-1893 after a single oral (PO) administration
时间窗: Day 8
Pharmacokinetics PK Vz/F: Plasma Vz/F
Cumulative amount of drug excreted in urine of HRS-1893 after a single oral administration
时间窗: Day 8
Cumulative amount of drug excreted in urine (Ae,ur)
Cumulative percentage of dose recovered in urine of HRS-1893 after a single oral administration:
时间窗: Day 8
Cumulative percentage of dose recovered in urine (%Ae,ur)
Renal clearance of HRS-1893 after a single oral administration
时间窗: Day 8
Renal clearance (CLr)
次要结局
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events(Day 8)