Site Selection for Intracutaneous Saline Delivery

Study Overview
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Brief Summary
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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
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Test ability to inject saline into various sites on body.

Official Title
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Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array

Conditions
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Intracutaneous Drug Delivery

Intervention / Treatment
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* Device: Injection to deltoid
* Device: Injection to forearm
* Device: Injection to thigh


Participation Criteria
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Eligibility Criteria
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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 Diabetes 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection to deltoid<br>Deliver saline from FLUGEN 101.2 microneedle-based delivery device. | Device: Injection to deltoid<br>* Deliver 0.5 milliliters of saline intradermally<br>|
| Experimental: Injection to forearm<br>Deliver saline from FLUGEN 101.2 microneedle-based delivery device. | Device: Injection to forearm<br>* Deliver 0.5 milliliters of saline intradermally<br>|
| Experimental: Injection to thigh<br>Deliver saline from FLUGEN 101.2 microneedle-based delivery device. | Device: Injection to thigh<br>* Deliver 0.5 milliliters of saline intradermally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Observe injection sites for change of appearance post-dose including wheal formation or resolution. | 30 minutes, 24 hours, 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device. | Evaluate ability of device to dispense targeted dose volume. | 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microneedle-based array, hollow microneedle, intracutaneous, drug delivery, vaccine delivery