Safety and Early Effectiveness Study of HN2301 Injection in Adults with Autoimmune Diseases Including Lupus, Scleroderma, and Rheumatoid Arthritis

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of HN2301 injection in people with autoimmune diseases such as Systemic Lupus Erythematosus SLE, Systemic Sclerosis SSc, and Rheumatoid Arthritis RA. This is an open-label, single-arm, exploratory clinical trial designed to study these conditions in adults aged 18 to 69 years. The study is sponsored by Shenzhen MagicRNA Biotechnology Co., Ltd and focuses on treatment outcomes and safety monitoring. Participants will receive HN2301 injections starting at a low dose, with the possibility of dose increases depending on safety and effectiveness as defined by the study protocol. The treatment period includes specific dosing days, and the study is planned to continue until 2028. This phase 1 study aims to establish safe dosing levels and gather preliminary data on the drugs effects on autoimmune conditions. Throughout the study, participants will undergo regular assessments including blood tests to monitor immune cell counts and organ functions. Researchers will measure treatment-emergent adverse events up to 3 months and track various disease activity scores and patient assessments over 12 months. These include measures like the SLEDAI-2K, Physician Global Assessment, and skin scoring. Safety and effectiveness will be closely monitored, and participants will be evaluated for changes in symptoms and overall health during the trial.

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）