A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •The subjects voluntarily signed the informed consent form.
- •Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible .
- •ASA classification is Grade I (only Parts Two and three)
- •Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
- •Adopt efficient contraceptive measures
排除标准
- •Those with a past or current clinical acute or chronic disease
- •Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
- •Those with a history of neuromuscular diseases or poliomyelitis
- •Those with a history of anesthesia complications.
- •Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
- •The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance
- •The subject has a history of severe systemic allergies for any reason.
- •The subjects took steroid hormone drugs within 7 half-lives or 14 days before administrationSmoke ≥5 cigarettes per day within 3 months prior to the study.
- •History of drug abuse.
- •Those who the researchers considered unsuitable for inclusion
研究组 & 干预措施
Dose Level：A1(Part1)
Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.
干预措施: HRS-2162 (Drug)
Dose Level：A1(Part1)
Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.
干预措施: Placebo (Drug)
Dose Level：A2(Part1) .
Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.
干预措施: HRS-2162 (Drug)
Dose Level：A2(Part1) .
Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.
干预措施: Placebo (Drug)
Dose Level：B(Part1+Part2)
Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.
干预措施: HRS-2162 (Drug)
Dose Level：B(Part1+Part2)
Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.
干预措施: Placebo (Drug)
Dose Level：C(Part1)
Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.
干预措施: HRS-2162 (Drug)
Dose Level：C(Part1)
Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.
干预措施: Placebo (Drug)
Dose Level：D(Part1+Part3)
Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.
干预措施: HRS-2162 (Drug)
Dose Level：D(Part1+Part3)
Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.
干预措施: Placebo (Drug)
Dose Level：E(Part1)
Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.
干预措施: HRS-2162 (Drug)
Dose Level：E(Part1)
Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.
干预措施: Placebo (Drug)
Dose Level：F(Part3)
Subject will receive HRS-2162 at dose level F
干预措施: HRS-2162 (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: From ICF signing date to Day7
次要结局
- Maximum observed concentration of HRS-2162 (Cmax)(0 hour to 24 hour after administration)
- Half-life (T1/2) of HRS-2162(0 hour to 24 hour after administration)
- Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value)(0 hour to 1 hour after administration)
- Area under the serum concentration time curve (AUC) of HRS-2162(0 hour to 24 hour after administration)
- Clearance (CL) of HRS-2162(0 hour to 24 hour after administration)
- Volume of distribution (Vz) of HRS-2162(0 hour to 24 hour after administration)
- Time to maximum observed concentration (Tmax) of HRS-2162(0 hour to 24 hour after administration)