NCT01423656已完成1 期
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
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
- LEO Pharma
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments
研究概览
简要总结
The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.
The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
- •Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
排除标准
- •Subjects who suffer from, or show signs of eczema or other skin lesions.
- •Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
- •Subjects with a significant history of drug allergy as determined by the Investigator.
- •Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
研究组 & 干预措施
LEO 29102
Experimental
干预措施: LEO 29102 (Drug)
LEO 29102 vehicle
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments
时间窗: 7 days after last dosing
次要结局
- LEO 29102 and metabolites in blood and urine(72 hours after dosing)
研究者
研究点 (1)
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