NCT02106260已完成1 期
A Phase I/IIa Open-label First-in-Human Study to Assess Safety and Pharmacokinetics and Explore Biomarker Effects of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Subjects With Cutaneous Warts
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
- 12
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of CLS003
研究概览
简要总结
This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
- •Body mass index (BMI) between 18 and 30kg/m2, inclusive
- •Fitzpatrick skin type I-II-III-IV
- •At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
排除标准
- •For women, a positive pregnancy test and/or nursing at screening
- •A positive test for drugs of abuse at screening
- •History of alcohol or illicit drug abuse
- •Positive test results for Hepatitis B, Hepatitis C or HIV
- •Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
- •Have received cryotherapy in the treatment area within 60 days prior to enrollment
- •Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
研究组 & 干预措施
CLS003
Experimental
干预措施: CLS003 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of CLS003
时间窗: 7 days
Number of participants with adverse events
时间窗: 7 days
Peak Plasma Concentration (Cmax) of CLS003
时间窗: 7 days
Time to reach Cmax (Tmax)
时间窗: 7 days
次要结局
- Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load(7 days)
研究者
研究点 (1)
Loading locations...
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