drugset / Trial / NCT06298071
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
Phase 1
Recruiting
36 enrolled
Shanghai Institute Of Biological Products
The First Affiliated Hospital of Bengbu Medical University · collabThe First Affiliated Hospital of Henan University of Science and Technology · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-03
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIBP-R002 | Unknown | 4 mg | Other |
| Subject | SIBP-R002 | Unknown | 8 mg | Other |
| Subject | SIBP-R002 | Unknown | 12 mg | Other |
| Background | Methotrexate | Small molecule | 15 mg | Oral |