A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Subcutaneous Administration of SHR-2173 in Healthy Participants
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - Cmax
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 SHR-2173 in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Main inclusion criteria
- •Healthy white participants.
- •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.
- •Male aged between 18 to 45 years of age (inclusive)
- •Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- •Men and WOCBP must agree to take highly effective contraceptive methods
排除标准
- •History or evidence of clinically significant disorders.
- •Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study or same class drug or any component of it.
- •Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
- •The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection.
- •History of excessive smoking in the past 1 month prior to screening
- •History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
- •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
SHR-2173 single dose
Single dose of SHR-2173/ given subcutaneously
干预措施: SHR-2173 Injection/SHR-2173 placebo (Drug)
SHR-2173 placebo single dose
Single dose of SHR-2173/placebo given subcutaneously
干预措施: SHR-2173 Injection/SHR-2173 placebo (Drug)
结局指标
主要结局
Pharmacokinetics - Cmax
时间窗: Day 71
Maximum observed plasma concentration (Cmax)
Pharmacokinetics - AUC₀-t
时间窗: Day 71
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Pharmacokinetics - AUC₀-inf
时间窗: Day 71
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Pharmacokinetics - Tmax
时间窗: Day 71
Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetics - t½
时间窗: Day 71
Terminal elimination half-life (t½)
Immunogenicity - Anti-Drug Antibody (ADA)
时间窗: Day 71
Incidence and onset time of anti-drug antibody (ADA)
次要结局
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events(Day 71)