NCT01723241已完成1 期
A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose Study to Assess the Safety and Tolerability of XAF5 Gel Applied to the Skin of Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Must understand and provide informed consent
- •Skin upon which a reaction would be visible
- •Body weight >= 70 kg
排除标准
- •Any active skin disease
- •History of skin hypersensitivity
- •Clinically significant abnormality on physical exam, ECG, or laboratory tests
- •Positive test for HIV, Hepatitis B, or Hepatitis C
研究组 & 干预措施
XAF5
Experimental
干预措施: XAF5, concentration A (Drug)
XAF5
Experimental
干预措施: XAF5, concentration B (Drug)
XAF5
Experimental
干预措施: XAF5, concentration C (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
研究者
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