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NCT01767337 Clinical Trial

Intracutaneous Delivery of Varied Dose Volumes of Saline

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01767337
Other study ID # FGN-NSR-2012-002
Secondary ID
Status Completed
Phase N/A
First received January 9, 2013
Last updated July 31, 2017
Start date December 2012
Est. completion date December 2012

Study information
Verified date July 2017
Source FluGen Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• FLUGEN 101.2 device

Locations
Country Name City State
United States Accelovance Inc Melbourne Florida

Sponsors (2)
Lead Sponsor Collaborator
FluGen Inc Accelovance

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution. 30 minutes, 24 hours, ~ 1 week
Secondary A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device. Evaluate ability of device to dispense targeted dose volume. 3 minutes
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