Intracutaneous Delivery of Varied Dose Volumes of Saline

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

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.

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

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.