Site Selection for Intracutaneous Saline Delivery
This study has been completed.
Pearl Pathways, LLC
Information provided by (Responsible Party):
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013
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.
Intracutaneous Drug Delivery
Device: FLUGEN 101.2 microneedle-based delivery device
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Evaluate ability of device to dispense targeted dose volume.
|Study Start Date:||December 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Injection site selection
Deliver 0.5 milliliters of saline to deltoid, forearm and thigh of subjects.
|Device: FLUGEN 101.2 microneedle-based delivery device|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767324
|United States, Florida|
|Melbourne, Florida, United States, 32935|
Sponsors and Collaborators
Pearl Pathways, LLC
|Study Director:||Renee Herber||FluGen Inc|
|Principal Investigator:||Murray A Kimmel, DO||Accelovance Inc.|