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The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental |
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| group 2 | Experimental |
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| group 3 | Experimental |
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| group 4 | Placebo Comparator | drug: JW normal saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC1102 | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of GC1102 when repeatedly administered by intravenous injection to healthy male adults |
| screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of GC1102 when repeatedly administered by intravenous injection to healthy male adults |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, MD, PhD | Department of clinical pharmacology and therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of clinical pharmacology and therapeutics | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| JW normal saline | Other |
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| 1)1d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 2) 2d~6d:predose(0h) 3) 7d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 4) 8d, 9d, 14d, 21d, 28d: 0h |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |