NCT06762600招募中1 期
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of HRS-4729 Injection in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study.
- •Male or female subjects; aged 18 to 55 years.
- •Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).
排除标准
- •A history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial.
- •A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.
- •Subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period.
- •Participation in any drug or medical device clinical trial within 3 months prior to screening.
- •Any abnormal physical examination, vital signs, laboratory tests, chest X-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation.
- •Clinically significant abnormalities on 12-lead ECG as determined by the investigator.
- •Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.
研究组 & 干预措施
Treatment group 2
Placebo Comparator
干预措施: HRS-4729 injection placebo (Drug)
Treatment group 2
Placebo Comparator
干预措施: Acetaminophen (Drug)
Treatment group 3
Experimental
干预措施: HRS9531 injection (Drug)
Treatment group 4
Placebo Comparator
干预措施: HRS9531 injection placebo (Drug)
Treatment group 1
Experimental
干预措施: HRS-4729 injection (Drug)
Treatment group 1
Experimental
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Screening period up to day 43.
次要结局
- The maximum plasma concentration (Cmax)(Post-dose at day 1 to day 43.)
- Time to maximum plasma concentration (Tmax)(Post-dose at day 1 to day 43.)
- Terminal half-life (t1/2)(Post-dose at day 1 to day 43.)
- Apparent clearance (CL/F)(Post-dose at day 1 to day 43.)
- Apparent volume of distribution (Vz/F)(Post-dose at day 1 to day 43.)
- Anti-HRS-4729 antibodies(Post-dose at day 1 to day 43.)
- Changes from baseline in Fasting Body Weight(Run-in Period up to Day 113.)
- Changes from baseline in Fasting Plasma Glucose(Run-in Period up to Day 113.)
- Changes from baseline in Fasting Insulin(Run-in Period up to Day 113.)
- Changes from baseline in Fasting C-Peptide(Run-in Period up to Day 113.)
- Total fat mass(Run-in Period up to Day 113.)
研究者
研究点 (1)
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