Intracutaneous Delivery of Varied Dose Volumes of Saline

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Device: FLUGEN 101.2 device

• Registration Number: NCT01767337
• Lead Sponsor: FluGen Inc

Brief Summary

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

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

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
injection of 0.25 mL saline	FLUGEN 101.2 device	deliver from FluGen 101.2 device
Injection of 0.5 mL saline	FLUGEN 101.2 device	deliver from FluGen 101.2 device
injection of 0.1 mL saline	FLUGEN 101.2 device	deliver from FluGen 101.2 device

Primary Outcome Measures

Name	Time	Method
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.	30 minutes, 24 hours, ~ 1 week	Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.

Secondary Outcome Measures

Name	Time	Method
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.	3 minutes	Evaluate ability of device to dispense targeted dose volume.

Trial Locations

Locations (1)

Accelovance Inc; 🇺🇸 Melbourne, Florida, United States