Intracutaneous Delivery of Varied Dose Volumes of Saline

July 31, 2017 updated by: FluGen Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Melbourne, Florida, United States, 32935
        • Accelovance Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: injection of 0.1 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Names:
  • FLUGEN 101.2
Experimental: injection of 0.25 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Names:
  • FLUGEN 101.2
Experimental: Injection of 0.5 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Names:
  • FLUGEN 101.2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 minutes, 24 hours, ~ 1 week
Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.
30 minutes, 24 hours, ~ 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FluGen Inc

Collaborators

Accelovance

Investigators

  • Study Director: Renee Herber, FluGen Inc
  • Principal Investigator: Murray A Kimmel, DO, Accelovance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 14, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FGN-NSR-2012-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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