Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs
研究概览
简要总结
Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin exposed to ultraviolet radiation
详细描述
This is an exploratory study, no primary or secondary endpoints are being defined.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •Fitzpatrick skin type II or III
- •Women not childbearing potential or highly effective contraception
排除标准
- •Pregnancy, lactation
- •Drug abuse
- •Clinically significant illness
- •Positive COVID 19 test at screening or COVID 19 infection in the past
研究组 & 干预措施
ACD440
Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure.
干预措施: ACD440 (Drug)
Placebo
Subjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure.
干预措施: PLAC (Drug)
结局指标
主要结局
Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs
时间窗: 5 Days
Not defined as primary as per protocol, but system does not seem to allow omittance of primaries
次要结局
未报告次要终点