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Site Selection for Intracutaneous Saline Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767324
First Posted: January 14, 2013
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Accelovance
Information provided by (Responsible Party):
FluGen Inc
  Purpose
The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.

Condition Intervention
Intracutaneous Drug Delivery Device: Injection to deltoid Device: Injection to forearm Device: Injection to thigh

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array

Further study details as provided by FluGen Inc:

Primary Outcome Measures:
  • The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time. [ Time Frame: 30 minutes, 24 hours, 1 week ]
    Observe injection sites for change of appearance post-dose including wheal formation or resolution.


Secondary Outcome Measures:
  • A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device. [ Time Frame: 3 minutes ]
    Evaluate ability of device to dispense targeted dose volume.


Enrollment: 12
Study Start Date: December 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Injection to deltoid
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Device: Injection to deltoid
Deliver 0.5 milliliters of saline intradermally
Experimental: Injection to forearm
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Device: Injection to forearm
Deliver 0.5 milliliters of saline intradermally
Experimental: Injection to thigh
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Device: Injection to thigh
Deliver 0.5 milliliters of saline intradermally

Detailed Description:
Test ability to inject saline into various sites on body.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767324


Locations
United States, Florida
Accelovance Inc
Melbourne, Florida, United States, 32935
Sponsors and Collaborators
FluGen Inc
Accelovance
Investigators
Study Director: Renee Herber FluGen Inc
Principal Investigator: Murray A Kimmel, DO Accelovance
  More Information

Responsible Party: FluGen Inc
ClinicalTrials.gov Identifier: NCT01767324     History of Changes
Other Study ID Numbers: FGN-NSR-2012-001
First Submitted: January 9, 2013
First Posted: January 14, 2013
Last Update Posted: August 2, 2017
Last Verified: July 2017

Keywords provided by FluGen Inc:
microneedle-based array
hollow microneedle
intracutaneous
drug delivery
vaccine delivery