Gout Clinical Trial
Official title:
A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics, and Initial Efficacy of Single and Multiple Dosing of Peguricase for Injection With Methotrexate in Patients With Gout.
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics, and initial efficacy of single and multiple dosing of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs. This study is a phase Ib single and multiple dosing, dose-increasing. Three dose groups of 4, 8 or 12 mg were planned, then exploring the most appropriate dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. ;
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|---|---|---|---|
| Completed |
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