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

NCT06857214 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-06-24

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

GNC-038

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT06857214 on ClinicalTrials.gov