A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single or Multiple Subcutaneous Injections in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study is a phase 1 single dose or multiple doses escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2001 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
- •Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
- •Age 18 ~ 55 years old (including boundary value), male or female;
- •Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
- •Participants who are overtly healthy as determined by medical history and physical examination.;
- •Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.
排除标准
- •Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
- •Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
- •Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;
研究组 & 干预措施
Cohort 7
A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 1
A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 1
A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 2
A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 2
A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 3
A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 3
A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 4
A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 4
A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 5
A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 5
A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 6
A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 6
A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 7
A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 8
A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 8
A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 9
A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 9
A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 10
A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 10
A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 11
A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 11
A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
干预措施: Placebo (Drug)
Cohort 12
A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.
干预措施: SHR-2001 (Drug)
Cohort 12
A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: Start of Treatment to end of study (approximately 64 days).
Incidence and severity of adverse events
次要结局
- Pharmacokinetics-AUC0-t(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-Cmax(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 64 days).)
- Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 64 days).)
- Anti-Drug antibody(Start of Treatment to end of study (approximately 64 days).)