NCT01159730已完成2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers
Vascular Biogenics Ltd. operating as VBL Therapeutics1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female patients, ≥18 to ≤75 years of age;
排除标准
- •Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
- •Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis);
- •Subjects with a history of coronary events within the last 6 months;
研究组 & 干预措施
Multiple doses of VB-201
Experimental
干预措施: VB-201 or Placebo (Drug)
Placebo
Placebo Comparator
干预措施: VB-201 or Placebo (Drug)
研究者
研究点 (1)
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