NCT05152277已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 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
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- •Age 18-55 years on the date of signing informed consent (inclusive);
- •Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive);
- •Subjects with good general health, no clinically significant abnormalities.
排除标准
- •With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study;
- •Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
- •Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
- •Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months;
- •Allergic constitution includes severe drug allergy or history of drug allergy;
- •Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive;
- •Breast-feeding women;
- •The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
研究组 & 干预措施
Single dose escalation of HRS9531 injection in healthy subjects
Experimental
干预措施: HRS9531 (Drug)
Single dose of placebo in healthy adults
Placebo Comparator
干预措施: placebo (Other)
Multiple dose escalation of HRS9531 injection in healthy subjects
Experimental
干预措施: HRS9531 (Drug)
Multiple dose of placebo in healthy adults
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Number of Adverse Events
时间窗: Start of Treatment to end of study (approximately 7 weeks or 9 weeks)
A summary of adverse events, including Serious Adverse Events(SAEs)
次要结局
- Area under the plasma concentration-time curve (AUC) of HRS9531(Start of Treatment to end of study (approximately 7 weeks))
- AUC of HRS9531(Start of Treatment to end of study (approximately 9 weeks))
- Glucose concentration(Start of Treatment to end of study (approximately 9 weeks))
- Immunogenicity qualitative(Start of Treatment to end of study (approximately 9 weeks))
研究者
研究点 (1)
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