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Intracutaneous Delivery of Varied Dose Volumes of Saline

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ClinicalTrials.gov Identifier: NCT01767337
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Accelovance
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Influenza Device: FLUGEN 101.2 device Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
Study Start Date : December 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: injection of 0.1 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Name: FLUGEN 101.2
Experimental: injection of 0.25 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Name: FLUGEN 101.2
Experimental: Injection of 0.5 mL saline
deliver from FluGen 101.2 device
Device: FLUGEN 101.2 device
Other Name: FLUGEN 101.2



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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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, 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.

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): NCT01767337


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

Responsible Party: FluGen Inc
ClinicalTrials.gov Identifier: NCT01767337     History of Changes
Other Study ID Numbers: FGN-NSR-2012-002
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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