NCT01595360已完成1 期
A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
Thrombotargets Europe S.L1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
详细描述
As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either
- •Subjects who are able and willing to provide written and signed informed consent
- •All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.
排除标准
- •Subjects with personal and family history that could affect correct hemostasis
- •Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura
- •Subject with hipersensivity of TT-173 of any of its components or has a known allergy.
- •Subjects who are unable to adequately follow or understand the instructions and requirements of the study.
- •Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
TT-173
Experimental
TT-173
干预措施: TT-173 (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 4 months
次要结局
- Cmax, Tmax, AUC and bioavailability(48 h)
- Determine the presence of coagulation disorders(4 months)
- Determine the immune responses to TT-173(4 months)
- Time to hemostasis until cessation of bleeding(time 0 until cessation of bleeding)
研究者
研究点 (1)
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