NCT00911495已完成1 期
Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease
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
- 15
- 试验地点
- 3
- 主要终点
- Safety as Measured by the Number of Participants With Adverse Events
研究概览
简要总结
This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 45 years
- •Established diagnosis of SCD-SS or SCD-SB0-thal
- •At medical baseline, with no evidence of worsening of disease over the last 3 months
- •Available and agree to return for follow-up visits for the full duration of the study
- •Able to cooperate with study procedures
- •Documented and observed written informed consent
排除标准
- •Vaso-occlusive crisis
- •Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion
- •Currently receiving, or has received within the previous 4 weeks, any other investigational agent
- •Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study
研究组 & 干预措施
GMI-1070
Experimental
干预措施: GMI-1070 (Drug)
结局指标
主要结局
Safety as Measured by the Number of Participants With Adverse Events
时间窗: 28 days
次要结局
- Volume of the Peripheral Compartment(48 hours)
- Total Plasma Clearance(48 hours)
- Volume of the Central Compartment(48 hours)
- Intercompartmental Clearance(48 hours)
研究者
研究点 (3)
Loading locations...
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