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This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: group1 | Experimental | injection;strength;4mg |
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| Experimental: group2 | Experimental | injection;strength;8mg |
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| Experimental: group3 | Experimental | injection;strength;12mg |
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| Experimental: group4 | Experimental | injection;strength;16mg |
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| Experimental: group5 | Experimental | injection;strength;20mg |
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| Placebo control group | Placebo Comparator | The same volume of placebo as SSS11 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Recombinant Candida Utilis Uricase for Injection | Drug | According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome was safety. | Assessment AEs by frequency and severity | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between post administration blood uric acid and baseline | up to 12 weeks | |
| Duration of blood uric acid<360 μ mol/L | up to 12 weeks | |
| Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hejian zou, professor | Contact | 021-52889999 | mail@hjzou.com/zhangj_fudan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HuaShan Hospital Fudan University project, ShangHai, China | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
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| up to 12 weeks |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |