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

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.

NCT Number	NCT07752810
Lead Sponsor	Hangzhou Grand Biologic Pharmaceutical, Inc.
Conditions	Gout
Enrollment	90 participants
Start Date	2022-06-23
Primary Completion	2024-12-06 (estimated)
Study Completion	2025-05-19 (estimated)
Updated on ClinicalTrials.gov	2026-08-07