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Intracutaneous Delivery of Varied Dose Volumes of Saline

This study has been completed.
Sponsor:
Collaborators:
Pearl Pathways, LLC
Accelovance Inc.
Information provided by (Responsible Party):
FluGen Inc
ClinicalTrials.gov Identifier:
NCT01767337
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Intracutaneous Drug Delivery
 Device: FLUGEN 101.2 microneedle-based delivery device

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by FluGen Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent 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 ] [ Designated as safety issue: No ]
    Evaluate ability of device to dispense targeted dose volume.


Enrollment: 24
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: Delivery volume
Deliver 0.1, 0.25 and 0.5 mL volumes of saline via FLUGEN 101.2 device to non-overlapping injection sites.
 Device: FLUGEN 101.2 microneedle-based delivery device
Other Name: FLUGEN 101.2

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767337

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

No publications provided

Responsible Party: FluGen Inc
ClinicalTrials.gov Identifier: NCT01767337     History of Changes
Other Study ID Numbers: FGN-NSR-2012-002
Study First Received: January 9, 2013
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013