NCT07200596已完成1 期
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose Subcutaneous Injection of SHR-3045 in Healthy Subjects-A Randomized, Double-Blind, Dose-Escalating, Placebo-Controlled Phase I Study
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年10月8日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 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 a single-dose subcutaneous injection of SHR-3045 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
- •Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- •Subjects who can provide written informed consent.
- •Males or females aged 18-55 years (both inclusive).
- •Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).
- •No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
排除标准
- •Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
- •Known or suspected history of drug abuse.
- •Addiction to tobacco and alcohol.
- •Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
- •Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
研究组 & 干预措施
SHR-3045 Group
Experimental
干预措施: SHR-3045 Injection (Drug)
SHR-3045 Placebo Group
Placebo Comparator
干预措施: SHR-3045 Placebo Injection (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From screening period up to Day 113.
次要结局
- Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).(Post-dose at Day 1 to Day 113.)
- Maximum observed concentration of SHR-3045 (Cmax).(Post-dose at Day 1 to Day 113.)
- Time to maximum observed concentration of SHR-3045 (Tmax).(Post-dose at Day 1 to Day 113.)
- Apparent clearance of SHR-3045 (CL/F).(Post-dose at Day 1 to Day 113.)
- Apparent volume of distribution of SHR-3045 (Vz/F).(Post-dose at Day 1 to Day 113.)
- Terminal elimination half-life of SHR-3045 (t1/2).(Post-dose at Day 1 to Day 113.)
- Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).(Post-dose at Day 1 to Day 113.)
研究者
研究点 (2)
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