NCT07238647进行中（未招募）1 期
A Phase I, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous Administration of Single Ascending Doses of HRS-5817 in Obese Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants
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
- 否
入选标准
- •Participants aged between 18 to 55 years of age (inclusive)
- •Participants with body mass index (BMI) between 30.0 kg/m2 (inclusive) to 40.0 kg/m2 (inclusive) at screening.
- •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.
- •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
- •1. History or evidence of clinically significant disorders
- •Individuals with a weight change of more than 5kg within 3 months prior to the screening.
- •Participant with a history of or current endocrine disorders that may significantly influence body weight (e.g., Cushing's syndrome, hypothyroidism, hyperthyroidism), or with obesity resulting from pharmacotherapy, monogenic mutations, or hereditary obesity syndromes.
- •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.
- •Use of any GLP-1 receptor agonists (including but not limited to Liraglutide, Beneglitide, Semaglutide, and Tirzepatide, etc.) or any other prescription medications, OTC drugs and dietary supplements for weight loss (including but not limited to Orlistat, Naltrexone/Bupropion, Phentermine/Topiramate, ect.). within 3 months prior to screening, and no planned use for the study duration.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Experimental: HRS-5817 dose level 1
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 1)
干预措施: HRS-5817 (Drug)
Experimental: HRS-5817 dose level 2
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 2)
干预措施: HRS-5817 (Drug)
HRS-5817 dose level 3
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 3)
干预措施: HRS-5817 (Drug)
HRS-5817
Experimental
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
干预措施: HRS-5817 (Drug)
结局指标
主要结局
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
时间窗: Day 253
Number of participants with Adverse events and Serious adverse events
次要结局
- Pharmacokinetics - Cmax(Day 253)
- Pharmacokinetics - AUC₀-t(Day 253)
- Pharmacokinetics - Tmax(Day 253)
- Pharmacokinetics - t½(Day 253)
- Immunogenicity - Anti-Drug Antibody (ADA)(Day 253)
研究者
研究点 (1)
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