Intracutaneous Delivery of Varied Dose Volumes of Saline

Study Overview
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Brief Summary
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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.

Detailed Description
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An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.

Official Title
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Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array

Conditions
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Influenza

Intervention / Treatment
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* Device: FLUGEN 101.2 device


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, presence of 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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injection of 0.1 mL saline<br>deliver from FluGen 101.2 device | Device: FLUGEN 101.2 device<br> <br> * Other names: FLUGEN 101.2;|
| Experimental: injection of 0.25 mL saline<br>deliver from FluGen 101.2 device | Device: FLUGEN 101.2 device<br> <br> * Other names: FLUGEN 101.2;|
| Experimental: Injection of 0.5 mL saline<br>deliver from FluGen 101.2 device | Device: FLUGEN 101.2 device<br> <br> * Other names: FLUGEN 101.2;|

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 various saline volumes delivered 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 initial wheal formation and subsequent 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 delivery, hollow microneedle, intracutaneous, drug delivery