NCT06857214

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is divided into a phase Ia study and a phase Ib study. The phase Ib study has a randomized controlled design with a placebo control group. The phase Ia study has a single-arm design, and the phase Ib study will be carried out on the basis of the Phase Ia study.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-04
• Last updated: 2025-06-24

Locations

1 site across 1 country: China