NCT01780077已完成1 期
A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects
RXi Pharmaceuticals, Corp.0 个研究点目标入组 15 人开始时间: 2012年12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
- 15
- 主要终点
- To assess the safety and tolerability of multiple intradermal administrations of RXI-109
研究概览
简要总结
The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 21-50 years of age
- •General good health; if female not pregnant or lactating
- •Phototype 3 and above based on the Fitzpatrick scale.
排除标准
- •Pregnant or lactating
- •Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
- •Type 1 or 2 diabetes mellitus
- •A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator
研究组 & 干预措施
RXI-109
Experimental
干预措施: RXI-109 (Drug)
RXI-109
Experimental
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: RXI-109 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of multiple intradermal administrations of RXI-109
时间窗: 12 weeks
Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities
次要结局
- To assess the effect of multiple intradermal administrations of RXI-109 on scar formation(12 weeks)
研究者
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