Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia

Exclusion Criteria18

• Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
• Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173
• Received immunosuppressants (other than corticosteroids) such as Janus kinase \[JAK\] inhibitors or Bruton tyrosine kinase \[BTK\] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the first infusion of SHR-2173 (whichever is longer)
• Previous treatment with SHR-2173
• Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel, novel oral anticoagulants), except for low-dose acetylsalicylic acid
• History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia
• Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization
• Active viral, bacterial, or other infections (including tuberculosis \[TB\]) requiring systemic treatment at screening, or SARS-CoV-2 infection during screening, or history of clinically significant recurrent infections
• Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
• Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
• Diagnosis of myelodysplastic syndrome; history of or current malignancy within 5 years prior to screening (except for cured non-melanoma skin cancer, in situ carcinoma \[e.g., cervical, breast, bladder, prostate cancer\], and cancers in complete remission for at least 5 years with no evidence of recurrence)
• Previous splenectomy
• Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression
• Planned surgery during the dosing period
• Any severe and/or unstable pre-existing medical, psychiatric, or other conditions that the investigator judges may interfere with patient safety, obtaining informed consent, or compliance with study procedures
• Allergic constitution (e.g., allergies to two or more drugs, foods, or pollens) or known hypersensitivity (immediate or delayed) or atopic reactions to the study drug (including excipients, monoclonal antibodies)
• Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)
• Females who are lactating or pregnant (positive serum or urine β-human chorionic gonadotropin \[hCG\]) at screening or on Day 1 of Week 1 prior to administration