NCT01539915已完成1 期
A Single Center, Open Label Exploratory Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Topically Administered BCT194 in Dermal Interstitial Fluid in Psoriatic Patients Using Open Flow Microperfusion
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
- change in Maximum dermal interstitial concentration of BCT194
研究概览
简要总结
This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BCT194
Experimental
干预措施: BCT194 (Drug)
结局指标
主要结局
change in Maximum dermal interstitial concentration of BCT194
时间窗: Day 1 and day 8
Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints
Area under the curve interstitial concentrations of BCT194
时间窗: day 1 and day 8
Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints
次要结局
- Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)(day 1 and day 8)
- Change in plaque PASI scores of psoriasis lesions(day 1 and day 8)
- BCT194 concentrations in skin biopsies(day 1 and day 8)
- Change in Local tolerability score(Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13)
研究者
研究点 (1)
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