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A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

NCT05588908 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-10-20

No results posted yet for this study

Summary

The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.

Conditions

  • Acute Gout

Interventions

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib)

100 mg subcutaneous (s.c) once

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib)

200 mg subcutaneous (s.c) once

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)

300 mg subcutaneous (s.c) once

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase II)

one s.c. injection of SSGJ-613 once, on Day 1.

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection low dose 300 mg (phase II)

one s.c. injection of SSGJ-613 once, on Day 1.

DRUG

Compound Betamethasone Injection (phase II)

1 mL i.m. once on Day 1

OTHER

Placebo (phase II)

Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hejian Zou, MD · Shanghai Huanshan Hospital Fudan University-Rheumatology

  • Qinghong Zhou, MD · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2023-09-30
Completion
2023-11-30

Countries

  • China

Study Locations

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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 NCT05588908 on ClinicalTrials.gov