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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 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
研究组 & 干预措施
ELAPR001
Active Comparator
Tropoelastin 0.1ml SC implant
干预措施: ELAPR (Device)
ELAPR002
Active Comparator
Tropoelastin 0.1ml SC implant
干预措施: ELAPR (Device)
ELAPR003
Active Comparator
Tropoelastin 0.1ml SC implant
干预措施: ELAPR (Device)
Saline
Placebo Comparator
Normal Saline 0.9%
干预措施: ELAPR (Device)
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 (1)
Loading locations...
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