CompletedInterventionalPhase 1Phase 2Last updated Aug 7, 2026

Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With Gout

A Multicenter, Open-Label, Dose-Escalation and Expansion Phase Ib/II Study to Evaluate the Safety, PK, and PD of Multiple Ascending Doses of HZBio1 in Patients With Gout

Overview

ClinicalTrials.gov ID: NCT07752810
Lead Sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.INDUSTRY
Brief Summary: Study YDHY (HZBio1)-001 (Ib/Ⅱ) is an open-label, dose-escalation and expansion, multicenter Phase Ib/II clinical trial conducted in China. The primary objectives were to evaluate the safety, tolerability, and PK of multiple-dose administration of HZBio1. The secondary objectives were to preliminarily explore the PD and immunogenicity of multiple-dose administration of HZBio1.
Study Type

Status

Overall Status: Completed
Start Date: Jun 23, 2022Actual
Primary Completion Date: Dec 6, 2024Actual
Completion Date: May 19, 2025Actual

Study Record Dates

First Submitted: Aug 2, 2026
First Submitted that Met QC Criteria: Aug 2, 2026
First Posted: Aug 7, 2026Actual
Last Update Submitted that Met QC Criteria: Aug 2, 2026
Last Update Posted: Aug 7, 2026Actual
Last Verified: May 2025

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