A Study of SHR-2173 in Participants With Primary IgA Nephropathy

Exclusion Criteria

• •\-
• •1、Presence of any of the following medical histories or comorbidities:
• •1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
• •2. A history of organ transplantation;
• •3. A history of splenectomy;
• •4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);
• •5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug
• •2、Use of any of the following drugs/treatments or participation in a clinical study:
• •1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);
• •2. Receivied immunosuppressive therapy within 12 weeks before randomization;
• •3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
• •4. Received a live / attenuated live vaccine administered within 4 weeks before randomization
• •3、History and examination related to infection:
• •1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;
• •2. Tuberculosis (TB) or occult TB infection (one of the following conditions) :
• •1. Presence of active TB or clinical symptoms of active TB at screening;
• •2. Signs of active TB on imaging examination within 3 months before screening
• •4、 General situation:
• •1\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.