Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FluGen Inc
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The primary objective is to evaluate the safety and tolerability/reactogenicity of various saline volumes delivered from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
研究概览
简要总结
This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the FLUGEN 101.2 investigational microneedle-based device.
详细描述
An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and/or understand and sign the Informed Consent form
排除标准
- •Medical history of acute or chronic skin disease
- •Active skin allergy or acute skin infection, presence of tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
- •Hirsute at any prospective injection site
- •High levels of anxiety or depression or history of psychosis
- •Abuse of alcohol or use of other drugs of abuse including tobacco
- •Pregnant or breastfeeding women
- •Any medical condition that may interfere with study protocol adherence including completion of study activities
- •Foreseeable inability to complete the study as scheduled.
研究组 & 干预措施
injection of 0.1 mL saline
deliver from FluGen 101.2 device
干预措施: FLUGEN 101.2 device (Device)
injection of 0.25 mL saline
deliver from FluGen 101.2 device
干预措施: FLUGEN 101.2 device (Device)
Injection of 0.5 mL saline
deliver from FluGen 101.2 device
干预措施: FLUGEN 101.2 device (Device)
结局指标
主要结局
The primary objective is to evaluate the safety and tolerability/reactogenicity of various saline volumes delivered from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
时间窗: 30 minutes, 24 hours, ~ 1 week
Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.
次要结局
- A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.(3 minutes)