NCT05369767进行中（未招募）1 期
A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection 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
- Other
- 盲法
- Triple (Participant, Care Provider, 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
- •males or females, aged 18-55;
- •body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg.
排除标准
- •previous medical history of coagulation or bleeding disorders;
- •known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
研究组 & 干预措施
SAD, SHR-2004
Experimental
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection
干预措施: SAD, SHR-2004 (Drug)
SAD, SHR-2004 placebo
Placebo Comparator
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
干预措施: SAD, SHR-2004 placebo (Drug)
结局指标
主要结局
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
时间窗: up to day 113
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Safety and Tolerability of SHR-1918 in Healthy SubjectsHyperlipemiaNCT05432544Beijing Suncadia Pharmaceuticals Co., Ltd72
已完成
1 期
A Phase I Study of SHR -2001 in Healthy SubjectsHealthyNCT05942612Guangdong Hengrui Pharmaceutical Co., Ltd72
招募中
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal WomenOsteoporosisNCT05930704Suzhou Suncadia Biopharmaceuticals Co., Ltd.45
终止
2 期
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA NephropathyPrimary IgA NephropathyNCT05847920Guangdong Hengrui Pharmaceutical Co., Ltd53
已完成
1 期
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITISModerate to Severe Atopic DermatitisNCT05197023Shanghai Hengrui Pharmaceutical Co., Ltd.21