NCT02936492终止1 期
Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 32
- 主要终点
- Cortisol serum levels for safety
研究概览
简要总结
Systemic safety following single and multiple dermal administration of BAY1003803
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Age: 18 to 64 years (inclusive) at the first screening visit
- •Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit
- •Non-smoker at least 3 months prior to study start and during the study
- •Healthy skin on which reddening can be easily recognized
排除标准
- •A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)
- •Infections and febrile illness within 4 week before the first study drug administration
- •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
- •Inoculations with live vaccine within 8 weeks before the first study drug administration
- •Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators
- •Human leukocyte antigen-DR (HLA-DR) < 15000 AB/monocyte
研究组 & 干预措施
BAY1003803
Experimental
Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
干预措施: BAY1003803 0.01% lipophilic cream (Drug)
BAY1003803
Experimental
Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
干预措施: BAY1003803 0.1% lipophilic cream (Drug)
BAY1003803
Experimental
Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
干预措施: BAY1003803 0.01% ointment (Drug)
Placebo
Placebo Comparator
Topical treatment using matching amount of placebo
干预措施: Lipophilic cream vehicle (Drug)
BAY1003803
Experimental
Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
干预措施: BAY1003803 0.1% ointment (Drug)
Placebo
Placebo Comparator
Topical treatment using matching amount of placebo
干预措施: Ointment vehicle (Drug)
Clobetasol propionate
Active Comparator
Topical treatment using 16.5 mg of clobetasol propionate per subject
干预措施: Clobetasol propionate (Drug)
结局指标
主要结局
Cortisol serum levels for safety
时间窗: Up to 2 weeks
Frequency of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 weeks
Nature of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 weeks
次要结局
- Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)(Day 1 to 3 at 8:00 am)
- Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)(Day 1 to 8 at 8:00 am)
- Maximum plasma concentration (Cmax) after single dose of BAY1003803(At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours)
- Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803(At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours)
- Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803(At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6))
- Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803(At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours)
- Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803(At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6))
研究者
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