Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol.

ABSTRACT:

Introduction

Hyperuricemia is a disease with abnormal purine metabolism, which leads to the increase of urate concentration. It is an independent risk factor for the occurrence and development of metabolic syndrome, type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, and gout. The enzyme urate oxidase can metabolize urate to allantoin, resulting in decreased urate concentrations. Pegylated the urate oxidase can extend half-life and decrease immunogenicity of the protein. This trial aims to evaluate the safety, tolerability, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of a new intravenous PEGylated urate oxidase produced by Xiuzheng Bio-Medicine Research Institute Co., Ltd.

Methods and analysis

A randomized, double-blind, placebo-c

SUBMITTER: Sun F 

PROVIDER: S-EPMC10758163 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature