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| Name | Class |
|---|---|
| Accelovance | INDUSTRY |
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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.
An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| injection of 0.1 mL saline | Experimental | deliver from FluGen 101.2 device |
|
| injection of 0.25 mL saline | Experimental | deliver from FluGen 101.2 device |
|
| Injection of 0.5 mL saline | Experimental | deliver from FluGen 101.2 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLUGEN 101.2 device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Herber | FluGen Inc | Study Director |
| Murray A Kimmel, DO | Accelovance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accelovance Inc | Melbourne | Florida | 32935 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |