NCT01467778已完成1 期
A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Safety and tolerability measured by the amount of adverse events and serious adverse events
研究概览
简要总结
This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.
详细描述
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health status
排除标准
- •Clinically significant abnormalities of haematology or biochemistry testing
- •Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
- •Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
- •History of keloid formation
- •Systemic corticosteroids within last 12 weeks
- •Diabetes or metabolic disorders
- •Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- •Pregnancy/lactation
- •A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
结局指标
主要结局
Safety and tolerability measured by the amount of adverse events and serious adverse events
时间窗: 6 weeks
To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events
次要结局
- Persistence(6 weeks)
研究者
研究点 (2)
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