Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FluGen Inc
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
Test ability to inject saline into various sites on body.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able to read and/or understand and sign the Informed Consent Form
Exclusion Criteria
- •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.
Arms & Interventions
Injection to deltoid
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Intervention: Injection to deltoid (Device)
Injection to forearm
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Intervention: Injection to forearm (Device)
Injection to thigh
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Intervention: Injection to thigh (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 30 minutes, 24 hours, 1 week
Observe injection sites for change of appearance post-dose including wheal formation or resolution.
Secondary Outcomes
- A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.(3 minutes)