NCT02223117已完成早期 1 期
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
Cellphire Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety Evaluation
研究概览
简要总结
This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum weight 110 pounds (50 kg)
- •Age 18-45 years
- •Able and willing to provide informed consent
- •Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion
- •Understands, speaks and reads standard English language
- •Normal healthy subject able to pass the universal blood donor history questionnaire and screen
排除标准
- •Breast-feeding female
- •At any time, previously pregnant female
- •Participation in an experimental drug/device study within the past 30 days.
研究组 & 干预措施
Placebo
Placebo Comparator
Buffer/placebo Control
干预措施: Placebo (Biological)
Intervention
Experimental
Thrombosomes
干预措施: Thrombosomes (Biological)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety Evaluation
时间窗: 60 days
次要结局
- Standard Hematology, Coagulation and Platelet Immunology Assessment(60 Days)
研究者
研究点 (1)
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