An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Skin Irritation Score of the Application Site
研究概览
简要总结
To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a male or female and aged between 20 and 45 years of age (inclusive)
- •Subject is of normal body weight as determined by a body-mass index (BMI) between 18 and 28 kg/m2
- •Subject is healthy as determined by EA (medical history, physical examination, skin evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)
- •Subject is surgically sterile; subject has been postmenopausal for at least 12 consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects)
排除标准
- •Subject has a history or complication of epilepsy and/or seizures
- •Subject has clinically relevant changes in the ECG, such as second- or third-degree AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA
- •Subject has a clinically relevant hepatic dysfunction
- •Subject has a clinically relevant renal dysfunction
- •Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
- •Subject has a history or complication of atopic or eczematous dermatitis, psoriasis, and/or an active skin disease or skin tumors
- •Subject has more than 1 known or suspected drug hypersensitivity, in particular to any component of the trial medication
- •Subject has a history of chronic alcohol or drug abuse within the last 5 years
- •Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab
- •Subject tests positive for alcohol and/or drugs at EA
- •Subject is taking any prohibited concomitant medication
- •Subject has a history or complication of narrow angle glaucoma
- •Subject has a history or complication of respiratory or cardiovascular disorders (e.g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)
- •Subject has a history or complication of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy
- •Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction, especially hyperthyroidism or other endocrine disorders
- •Subject has a history or complication of malignancy
研究组 & 干预措施
Topical Steroid
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
干预措施: Topical steroid (Dexamethasone) (Drug)
Topical antihistamine
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
干预措施: Topical antihistamine (Diphenhydramine) (Drug)
结局指标
主要结局
Skin Irritation Score of the Application Site
时间窗: 24 hours after 2 mg/24 hr patch removal
Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.
Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)
时间窗: 24 hours after 2 mg/24 hr patch removal
Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The score ranges from 0 (no itching) to 100 (strongest imaginable itching).
次要结局
- Skin Irritation Score After Patch Removal(Up to 72 hours after patch removal)
- Itching of Application Site Evaluated by VAS After Patch Removal(Up to 96 hours after patch removal)