NCT01359111已完成1 期
Phase I Performance and Safety Evaluation of an Intradermal Delivery Device
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of Injections Delivered to the Intradermal Layer of the Skin
研究概览
简要总结
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male participants ages 18 to 55 years.
- •Healthy enough to participate in the clinical trial per site investigator assessment.
- •Healthy skin on the upper deltoid region of both arms.
- •Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
- •Literate in English.
- •Available by telephone 48 hours after the study visit.
排除标准
- •Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
- •Unable to understand the study purpose or procedures.
结局指标
主要结局
Proportion of Injections Delivered to the Intradermal Layer of the Skin
时间窗: 1 day
The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.
次要结局
- Proportion of Participants With Safety Events(2 days)
- Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.(1 day)
研究者
研究点 (1)
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