NCT04772365已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 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
- Double (Participant, Investigator)
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
- •Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
- •Be able to comply with all the requirements and able to complete the study.
- •Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- •No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.
排除标准
- •Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
- •Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
- •Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
- •Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-1819 (Drug)
Treatment group B
Placebo Comparator
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（about 13 weeks）
Incidence and severity of adverse events
次要结局
- Pharmacokinetics-CL/F(Up to 13 weeks)
- Pharmacokinetics-Vz/F(Up to 13 weeks)
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 13 weeks))
- Pharmacokinetics-Cmax(Up to 13 weeks)
- Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17）(Up to 13 weeks)
- Pharmacokinetics-AUC0-last(Start of Treatment to end of study (about 13 weeks))
- Pharmacokinetics-Tmax(Up to 13 weeks)
- Pharmacokinetics-t1/2(Up to 13 weeks)
- Change from baseline to end of treatment for IgE(Up to 13 weeks)
- Immunogenicy of SHR-1819 after administration(Up to 13 weeks])
- Pharmacokinetics- Ctrough for multi-dose(Up to 13 weeks)
- Pharmacokinetics-AUCtau for multi-dose(Start of Treatment to end of study (about 13 weeks))
- Pharmacokinetics- Racc for multi-dose(Up to 13 weeks)
研究者
研究点 (1)
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