Intracutaneous Delivery of Varied Dose Volumes of Saline

FluGen

Status: Completed

Conditions: Influenza

Treatments: Device: FLUGEN 101.2 device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767337

FGN-NSR-2012-002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

injection of 0.1 mL saline

Experimental group

Description:

deliver from FluGen 101.2 device

Treatment:

Device: FLUGEN 101.2 device

injection of 0.25 mL saline

Experimental group

Description:

deliver from FluGen 101.2 device

Treatment:

Device: FLUGEN 101.2 device

Injection of 0.5 mL saline

Experimental group

Description:

deliver from FluGen 101.2 device

Treatment:

Device: FLUGEN 101.2 device