NCT06280768已完成1 期
A Phase Ib Clinical Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2004 Injection in Patients With Atrial Fibrillation
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年4月10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
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (including bleeding events)
研究概览
简要总结
This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
- •Male or female ≥ 40 years and < 80 years old；
- •History of atrial fibrillation or atrial flutter, or newly diagnosed atrial fibrillation or atrial flutter during the screening period, as documented by Holter ECG or 12-lead ECG at the time of screening or within 12 months prior to screening.
排除标准
- •Patients with a mechanical heart valve;
- •Rheumatic mitral stenosis or moderate to severe non-rheumatic mitral stenosis;
- •Atrial fibrillation or atrial flutter is caused by reversible causes, or successful ablation has been converted to sinus rhythm, or cardioversion or ablation surgery is planned during the study;
- •Concomitant poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg) at screening;
- •Those who are allergic to the trial drug or any component of the trial drug;
- •Unstable or severe liver, renal, cardiovascular, psychiatric, neurological, endocrine, hematological and other diseases at the time of screening, and the investigator judges that it is not suitable to participate in the study;
- •Females who are pregnant or lactating.
研究组 & 干预措施
SHR-2004 injection
Experimental
干预措施: SHR-2004 injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (including bleeding events)
时间窗: Up to 136 Days
次要结局
- Pharmacokinetics of Dupilumab: Elimination half life (t1/2)(Up to 136 Days)
- Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)(Up to 136 Days)
- Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)(Up to 136 Days)
- PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity(Up to 136 Days)
- PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)(Up to 136 Days)
- Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004(Up to 136 Days)
研究者
研究点 (1)
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