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Safety and PK/PD of Single-Dose Pegloticase (SIBP-R002) in Asymptomatic Hyperuricemia
NCT05302388Phase 1Completed
- Sponsor
- Shanghai Institute of Biological Products
- Start
- Apr 2022
- Primary completion
- Jan 2023
- Modality
- Replacement Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial in hyperuricemia comparing Pegloticase Group with Placebo Group (2 arms). Primary endpoints: Adverse Events at 35 days and Serious Adverse Events at 35 days. Started Apr 2022; status: completed.
02
Drugs
pegloticase
03
Conditions
hyperuricemia
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