ACTRN12610000871044已完成1 期
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years(—)
- 性别
- All
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
- •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
研究者
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