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| Name | Class |
|---|---|
| GeneOne Life Science, Inc. | INDUSTRY |
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To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.
This study will evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1mg dose group |
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| 2 | Experimental | 10mg dose group |
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| 3 | Experimental | 100mg dose group |
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| 4 | Experimental | 200mg dose group |
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| 5 | Experimental | 400mg dose group |
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| 6 | Experimental | 800mg dose group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VGX-1027 | Drug | Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan A Bart, MD | SNBL Clinical Pharmacology Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C518641 | 3-phenyl-4,5-dihydro-5-isoxazole acetic acid |
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