NCT02647853已完成1 期
A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
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
- 16
- 试验地点
- 1
- 主要终点
- Adverse Event rates
研究概览
简要总结
This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 40-70 years old
- •Healthy volunteers
- •Provision of informed consent
排除标准
- •History of skin hypersensitivity
- •Abnormality on screening assessments
研究组 & 干预措施
TAT4 Gel concentration A
Experimental
TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.
干预措施: TAT4 Gel concentration A (Drug)
TAT4 Gel concentration B
Experimental
TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.
干预措施: TAT4 Gel concentration B (Drug)
Placebo
Placebo Comparator
Placebo product once daily to 50 cm2 for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event rates
时间窗: 21 days
Adverse event rates by System Organ Class, as graded by current CTCAE
次要结局
- Plasma pharmacokinetics (Cmax)(Days 1 and 13)
- Plasma pharmacokinetics (AUC0-24)(Day 1 and 13)
- Plasma pharmacokinetics (Tmax)(Days 1 and 13)
研究者
研究点 (1)
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