A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-9231 in Healthy Caucasian Participants
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physical examination
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled study. The objective of this study is to evaluate the safety, tolerability, and PK profile of HRS-9231 injection following a single dose in healthy Caucasian participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy Caucasian participants;
- •Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- •Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
- •Women with body weight of ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass Index (BMI) between 18.0 and 32.0 kg/m2
排除标准
- •History or evidence of clinically significant disorders
- •Individuals with a history of drug allergies, specific allergies
- •Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to dosing, or plan to do surgeries during the study.
- •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.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
HRS-9231 or matching placebo Dose level 1
Dose level 1
干预措施: HRS-9231or matching placebo (Drug)
HRS-9231 or matching placebo Dose level 2
干预措施: HRS-9231or matching placebo (Drug)
结局指标
主要结局
Physical examination
时间窗: Day 8
Number of patients with clinically significant change in physical examination
ECG
时间窗: Day 8
Number of patients with clinically significant change from baseline in 12-ECG values
Injection site reaction
时间窗: Day 8
Number of patients with injection site reaction
Adverse events
时间窗: Day 8
Number of patients with adverse events (AEs) and serious adverse event (SAE)
Vital signs
时间窗: Day 8
Number of patients with clinically significant change from baseline in vital signs values
Laboratory
时间窗: Day 8
Number of patients with clinically significant change from baseline in laboratory examination
次要结局
- Pharmacokinetics PK MRTlast(Day 1)
- Pharmacokinetics PK t1/2(Day 1)
- Pharmacokinetics PK %Ae(Day 3)
- Pharmacokinetics PK ur(Day 3)
- Pharmacokinetics PK Cmax(Day 1)
- Pharmacokinetics PK AUC0-t(Day 1)
- Pharmacokinetics PK AUC0-inf(Day 1)
- Pharmacokinetics PK Tmax(Day 1)
- Pharmacokinetics PK CL(Day 1)
- Pharmacokinetics PK Vz(Day 1)
- Pharmacokinetics PK MRTinf(Day 1)
- Pharmacokinetics PK Ae(Day 3)
- Pharmacokinetics PK CLr(Day 3)