Overview

A Phase I Clinical Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia

Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Shanghai Institute Of Biological Products
Collaborator:
First Affiliated Hospital Bengbu Medical College
Treatments:
Dexamethasone
Diphenhydramine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Promethazine