RecruitingPhase 1NCT06857214

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus

A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

54 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

Summary

This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GNC-038 and a drug called Placebo for people with systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGNC-038

Administration by intravenous infusion. Once a week (IV, QW), twice in total.

DRUGPlacebo

The control group will be set up in phase Ib, and an appropriate dose will be selected based on phase Ia data.

Locations(1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06857214

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