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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-621 | Experimental | Intervention drug: UB-621 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-621 | Drug | 100 mg/ml, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 70 or 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration of UB-621 | Up to 70 or 112 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wing Wai Wong, MD | Taipei Veterans General Hoapital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |