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The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB224 2mg | Experimental | single dose |
|
| GB224 5mg | Experimental | single dose |
|
| GB224 10mg | Experimental | single dose |
|
| GB224 15mg | Experimental | single dose |
|
| GB224 20mg | Experimental | single dose |
|
| GB224 30mg | Experimental | single dose |
|
| Placebo 2mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB224 2mg | Biological | 2mg (100μL), single dose, abdominal subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adeverse Effect, AE | Adeverse Effect, AE | Up to 112 days. |
| Serious Adeverse Effect, AE | Serious Adeverse Effect, AE | Up to 112 days. |
| Maximum Tolerated Dose, MTD | Maximum Tolerated Dose, MTD | Up to 112 days. |
| Dose Limited Toxicity, DLT | Dose Limited Toxicity, DLT | Up to 112 days. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | AUC0-t | Up to 112 days. |
| Cmax | Cmax | Up to 112 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Yu, Master | Contact | 010-65260820 | Shawn.Yu@genorbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Fang, Ph.D | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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single dose |
|
| Placebo 5mg | Placebo Comparator | single dose |
|
| Placebo 10mg | Placebo Comparator | single dose |
|
| Placebo 15mg | Placebo Comparator | single dose |
|
| Placebo 20mg | Placebo Comparator | single dose |
|
| Placebo 30mg | Placebo Comparator | single dose |
|
| GB224 5mg | Biological | 5mg (250μL), single dose, abdominal subcutaneous injection |
|
|
| GB224 10mg | Biological | 10mg (500μL), single dose, abdominal subcutaneous injection |
|
|
| GB224 15mg | Biological | 15mg (750μL), single dose, abdominal subcutaneous injection |
|
|
| GB224 20mg | Biological | 20mg (1mL), single dose, abdominal subcutaneous injection |
|
|
| GB224 30mg | Biological | 30mg (1.5mL), single dose, abdominal subcutaneous injection |
|
|
| Placebo, 2mg | Other | 2mg (100μL), single dose, abdominal subcutaneous injection |
|
| Placebo, 5mg | Other | 5mg (250μL), single dose, abdominal subcutaneous injection |
|
| Placebo, 10mg | Other | 10mg (500μL), single dose, abdominal subcutaneous injection |
|
| Placebo, 15mg | Other | 15mg (750μL), single dose, abdominal subcutaneous injection |
|
| Placebo, 20mg | Other | 20mg (1mL), single dose, abdominal subcutaneous injection |
|
| Placebo, 30mg | Other | 30mg (1.5mL), single dose, abdominal subcutaneous injection |
|
| AUC0-∞ |
AUC0-∞ |
| Up to 112 days. |
| Tmax | Tmax | Up to 112 days. |
| Vd | Vd | Up to 112 days. |
| Ke | Ke | Up to 112 days. |
| Mean Retention Time, MRT | Mean Retention Time, MRT | Up to 112 days. |
| t1/2 | t1/2 | Up to 112 days. |
| CL | CL | Up to 112 days. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |