Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298071
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-28
Brief Title:
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout
Sponsor:
Shanghai Institute Of Biological Products
Organization:
Shanghai Institute Of Biological Products
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None