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drugset / Trial / NCT05302388

A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia

NCT05302388 ↗

Phase 1 Completed 45 enrolled Shanghai Institute Of Biological Products The First Affiliated Hospital of Bengbu Medical University · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main purpose To evaluate the safety and tolerability of pegloticase in subjects with asymptomatic hyperuricemia by single intravenous infusion at different doses, and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia. A secondary purpose To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of Pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia. Exploratory purpose Plasma uricase activity (pUox) analysis of pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.

Timeline

Start
2022-04-11
Primary completion
2023-01-09
Completion
2023-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegloticase Protein / enzyme biologic 1 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 2 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 4 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 8 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 12 mg Intravenous
Background Dexamethasone Small molecule 5 mg Intravenous
Background Diphenhydramine Unknown 10 mg Intramuscular
Background Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Background Methylprednisolone Other / unclassified 2 mg/kg Intravenous

Indications

No indication recorded.