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| Name | Class |
|---|---|
| Accelovance | INDUSTRY |
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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.
Test ability to inject saline into various sites on body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection to deltoid | Experimental | Deliver saline from FLUGEN 101.2 microneedle-based delivery device. |
|
| Injection to forearm | Experimental | Deliver saline from FLUGEN 101.2 microneedle-based delivery device. |
|
| Injection to thigh | Experimental | Deliver saline from FLUGEN 101.2 microneedle-based delivery device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection to deltoid | Device | Deliver 0.5 milliliters of saline intradermally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Observe injection sites for change of appearance post-dose including wheal formation or 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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| Injection to forearm |
| Device |
Deliver 0.5 milliliters of saline intradermally |
|
| Injection to thigh | Device | Deliver 0.5 milliliters of saline intradermally |
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