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To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSGJ-613 | Experimental | SSGJ-613,SC |
|
| Placebo | Placebo Comparator | Placebo, SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-613 | Drug | SSGJ-613 subcutaneous injection. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit. | The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations,electrocardiogram,laboratory tests and, etc.. | Up to Day 174 |
| Measure | Description | Time Frame |
|---|---|---|
| SSGJ-613 Concentration in Serum | The concentration of SSGJ-613 in Serum. | Up to Day 174 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Zhou, BS | Contact | +86 18911301578 | zhouqinghong@3sbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Qinghong Zhou, BS | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Study Director |
| Qian Chen, PhD | Shanghai Xuhui District Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Drug |
Placebo subcutaneous injection. |
|
| D000070657 |
| Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |