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

NCT07752810 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Phase 2: HZBio1 6mg

Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.

DRUG

Phase 2: HZBio1 9mg

Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.

DRUG

Phase 2: HZBio1 12mg

Participants receive intramuscular injections of HZBio1 at 6mg, 9mg, and 12 mg every two weeks. Participants receive a total of 14 administrations.

DRUG

Phase 1b: HZBio1 3mg

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

DRUG

Phase 1b: HZBio1 6mg

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

DRUG

Phase 1b: HZBio1 12mg

Participants receive HZBio1 at doses of 3mg, 6mg, and 12mg every two weeks for a total of six doses

Sponsors & Collaborators

  • Hangzhou Grand Biologic Pharmaceutical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2024-12-06
Completion
2025-05-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752810 on ClinicalTrials.gov