NCT01850849已完成1 期
A Phase I, First-in-Human, Vehicle Controlled, Single Ascending Dose Trial Evaluating the Safety, Tolerability and Pharmacokinetics in Male Subjects With AD and in Healthy Male Subjects of Cutaneous Application of LEO 39652 Cream
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
- 23
- 试验地点
- 2
- 主要终点
- Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments
研究概览
简要总结
The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA >2) for the whole body
- •AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)
- •Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive
排除标准
- •Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)
- •Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.
- •Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
- •History of or current cardiac arrhythmic disorder
- •Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.
- •Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator
研究组 & 干预措施
LEO 39652 cream
Experimental
Active drug
干预措施: LEO 39652 cream (Drug)
LEO 39652 cream vehicle
Placebo Comparator
Placebo drug
干预措施: cream vehicle (Drug)
结局指标
主要结局
Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments
时间窗: Up to 48 hours after dosing
次要结局
- LEO 39652 and metabolites in blood(Up to 48 hours after dosing)
研究者
研究点 (2)
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