Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
研究概览
简要总结
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
详细描述
In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.
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
- 3 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 3 years and <30 years.
- •Able to give informed consent.
- •English speaking with no language impairment
- •Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months
排除标准
- •History of reaction to peanuts
- •Major active medical problems of the oral cavity or use of medications that might change rates of salivation
结局指标
主要结局
Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
时间窗: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement
时间窗: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement
时间窗: 3 days
次要结局
未报告次要终点