Phase I Study Evaluating Safety, Effectiveness, and Dosing of GNC-038 Antibody Injection for Rheumatoid Arthritis Treatment

What this Trial Is About

Researchers are evaluating the safety, efficacy, and pharmacokineticpharmacodynamic properties of GNC-038, a tetra-specific antibody injection, in patients with rheumatoid arthritis. This phase I clinical study includes two parts a phase Ia single-arm study and a phase Ib randomized controlled study with a placebo group. The study aims to understand the treatments effects in patients who have moderate to severe rheumatoid arthritis and meet specific diagnostic criteria. Participants receive GNC-038 by intravenous infusion once a week for two doses in the first cycle. Those who show clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons require stopping. In phase Ib, a control group receives a placebo based on doses determined in phase Ia. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. During the study, participants will undergo regular safety and efficacy assessments, including monitoring adverse events and measuring drug levels in the blood. Researchers will evaluate rheumatoid arthritis activity using criteria such as ACR20 remission and quality of life changes over up to 24 months. Participants must follow scheduled visits, treatment plans, laboratory tests, and other study procedures throughout the study period.

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis