SP16 Inflammatory Response Inhibition Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) for C-reactive Protein (CRP)
研究概览
简要总结
This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.
详细描述
The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication.
SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SP16
Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection
干预措施: SP16 (Drug)
结局指标
主要结局
Area Under the Curve (AUC) for C-reactive Protein (CRP)
时间窗: Baseline, 72 hours, 14 days
This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP.
次要结局
- Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)(72 hours)
- Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days(365 days)
- Diagnosis of Heart Failure(365 days)