A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia

Asymptomatic Hyperuricemia Clinical Trial

Official title: A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability，Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia

Status Completed

Clinical Trial 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.

Clinical Trial Description

To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics analysis of pegloticase in subjects with asymptomatic hyperuricemia.

This is a phase I randomized, double-blind, placebo-controlled and dose-increasing single dosing study. Five dose groups of 1, 2, 4, 8 or 12 mg were planned to explore the most appropriate dose and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia. ;

Related Conditions & MeSH terms

• Asymptomatic Hyperuricemia
• Hyperuricemia

• NCT number: NCT05302388
• Study type: Interventional
• Source: Shanghai Institute Of Biological Products
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2022
• Completion date: January 9, 2023