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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06298071
Study type Interventional
Source Shanghai Institute Of Biological Products
Contact Dandan Chen, Master
Phone 86-021-62800991
Email ddchen.sh@sinopharm.com
Status Recruiting
Phase Phase 1
Start date March 3, 2023
Completion date December 30, 2025

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