NCT00891709已完成1 期
A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects
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
- 64
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability
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 male subjects.
The study is divided into one single dose part followed by a 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive).
- •Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation.
排除标准
- •Subjects who show signs of eczema or other skin lesions.
- •Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).
研究组 & 干预措施
1
Experimental
LEO 29102 2.5 mg/g cream
干预措施: LEO 29102 (Drug)
2
Placebo Comparator
LEO 29102 cream vehicle
干预措施: LEO 29102 (Drug)
结局指标
主要结局
To determine the safety and tolerability
次要结局
- To determine the pharmacokinetics
研究者
研究点 (1)
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