Intracutaneous Delivery of Varied Dose Volumes of Saline

Not Applicable

Completed

• Conditions: Influenza

• 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

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