NCT03352726已完成1 期
An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic 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
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)
研究概览
简要总结
The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged between 12-50 years
- •Physician-diagnosed peanut allergy
- •Subject currently following a strict peanut-free diet
- •Documented history of positive test to peanut-specific IgE (ImmunoCAP system) >0.7 kU/L
- •Positive peanut SPT with a largest wheal diameter ≥ 8 mm
排除标准
- •Uncontrolled asthma
- •Peanut allergen immunotherapy whatever the route, either ongoing or previously started and having lasted more than one month (>30 days)
- •Topical use of steroids within the past 14 days prior to the Screening SPT
- •Inability to discontinue short-acting antihistamines
- •Atopic dermatitis, eczema or urticaria on the areas to be tested
研究组 & 干预措施
DBV712 Solution for Skin Prick Test
Experimental
DBV712 In-House Reference Skin Prick Test preparation
干预措施: DBV712 IHRP (Drug)
结局指标
主要结局
Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)
时间窗: 1 day to 2 weeks
次要结局
- Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)(Throughout the study (1 day to 2 weeks))
研究者
研究点 (2)
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