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
  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
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, see Learn About Clinical Studies.

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 August 20, 2014