Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2012-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Injection to deltoid
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Injection to deltoid
Deliver 0.5 milliliters of saline intradermally
Injection to forearm
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Injection to forearm
Deliver 0.5 milliliters of saline intradermally
Injection to thigh
Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Injection to thigh
Deliver 0.5 milliliters of saline intradermally
Interventions
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Injection to deltoid
Deliver 0.5 milliliters of saline intradermally
Injection to forearm
Deliver 0.5 milliliters of saline intradermally
Injection to thigh
Deliver 0.5 milliliters of saline intradermally
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active skin allergy or acute skin infection, 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.
18 Years
49 Years
ALL
Yes
Sponsors
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Accelovance
INDUSTRY
FluGen Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Renee Herber
Role: STUDY_DIRECTOR
FluGen Inc
Murray A Kimmel, DO
Role: PRINCIPAL_INVESTIGATOR
Accelovance
Locations
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Accelovance Inc
Melbourne, Florida, United States
Countries
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Other Identifiers
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FGN-NSR-2012-001
Identifier Type: -
Identifier Source: org_study_id
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