NCT07318155招募中2 期
A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Subcutaneously Administered SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
Sirius Therapeutics Co., Ltd.1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年3月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percent change from baseline in time-averaged FXI antigen
研究概览
简要总结
The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •Males or females aged 18 to 75 years, inclusive.
- •Body mass index (BMI) between 18.0 and 35.0 kg/m2, inclusive.
- •History of chronic coronary and/or peripheral arterial disease
排除标准
- •Known bleeding disorder
- •Severe heart failure with known left ventricular ejection fraction <35%, or New York Heart Association (NYHA) class III or IV symptoms.
- •Genetic cardiomyopathies or other non-ischemic cardiomyopathies that are not related to atherosclerotic cardiovascular disease.
- •History of ethanol abuse or addictive drug use (cannabis products allowed) within 6 months of screening.
- •Receipt of an investigational drug (IP) within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study.
- •Previous use of SRSD107.
研究组 & 干预措施
SRSD107 dose level 1
Experimental
Administered S.C.
干预措施: SRSD107 (Drug)
SRSD107 dose level 2
Experimental
Administered S.C.
干预措施: SRSD107 (Drug)
SRSD107 dose level 3
Experimental
Administered S.C.
干预措施: SRSD107 (Drug)
SRSD107 dose level 4
Experimental
Administered S.C.
干预措施: SRSD107 (Drug)
Placebo
Placebo Comparator
Administered S.C.
干预措施: 0.9 % sodium chloride (Drug)
结局指标
主要结局
Percent change from baseline in time-averaged FXI antigen
时间窗: 72 weeks
次要结局
- Incidence of adverse events(72 weeks)
- Area under the concentration-time curve from time 0 to infinity of SRSD107(72 weeks)
- Time to the maximal concentration of SRSD107(72 weeks)
- Percent change from baseline in FXI antigen, FXI activity and aPTT(72 weeks)
- Maximal concentration of SRSD107(72 weeks)
研究者
研究点 (1)
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