Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving 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
- 12
- 试验地点
- 2
- 主要终点
- The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery 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
The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.
详细描述
Test ability to inject saline into various sites on body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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, 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 to deltoid
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
干预措施: Injection to deltoid (Device)
Injection to forearm
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
干预措施: Injection to forearm (Device)
Injection to thigh
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
干预措施: Injection to thigh (Device)
结局指标
主要结局
The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery 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 wheal formation or resolution.
次要结局
- A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.(3 minutes)