A Single-center, Randomized, Crossover, Open-label Phase I Study to Compare the Safety and Pharmacokinetics of SHR-1209 Given as Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
研究概览
简要总结
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. The study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
- •The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
- •Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and <28.0 kg/m2, weight of male must≥ 50.0 kg and <90.0 kg, and female≥ 45.0 kg and <90.0 kg;
- •The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.
排除标准
- •Serious infection within 3 months before screening;
- •History of food or drug allergy or atopic allergic disease (asthma, urticaria);
- •Positive blood pregnancy test;
- •Have a history of drug abuse;
- •Women who are pregnant or breastfeeding;
- •Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
研究组 & 干预措施
Treatment group A
干预措施: SHR-1209 single-site subcutaneous injection (Drug)
Treatment group A
干预措施: SHR-1209 multiple-site subcutaneous injections (Drug)
Treatment group B
干预措施: SHR-1209 single-site subcutaneous injection (Drug)
Treatment group B
干预措施: SHR-1209 multiple-site subcutaneous injections (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) was used to evaluate the injection site pain of single-site subcutaneous injection of SHR-1209.
时间窗: After injection in day 1 and day 57.
Visual Analog Scale (VAS) was used to evaluate the injection site pain of multiple-site subcutaneous injections of SHR-1209.
时间窗: After injections in day 1 and day 57.
Area under the curve (AUC0-56).
时间窗: After injection in day 1 up to day 56.
Peak time (Tmax) of SHR-1209.
时间窗: After injection in day 1 up to day 56.
Peak concentration (Cmax) of SHR-1209.
时间窗: After injection in day 1 up to day 56.
次要结局
- Subjects' preferred method of SHR-1209 administration between the tested injection regimens.(Day 68.)
- Incidence and severity of adverse events (AEs).(From Day 1 to Day 169.)
- Incidence and severity of serious adverse events (SAEs).(From Day 1 to Day 169.)