A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease

Exclusion Criteria

• •1. Known history of hypersensitivity to the investigational drug formulation or any of its components;
• •2. Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect drug administration and safety assessment;
• •3. Meeting any of the following criteria at screening:
• •1. Hemoglobin \< 60 g/L;
• •2. Platelet count \< 80 x 10\^9/L;
• •3. Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 2.5 x upper limit of normal (ULN), or total bilirubin \>= 1.5 x ULN; or serum creatinine (Cr) \>= 1.5 x ULN;
• •4. Positive for anti-human immunodeficiency virus (HIV) antibody;
• •5. Presence of any bleeding disorder other than von Willebrand disease \[hemophilia A or B, congenital coagulation factor VII deficiency, acquired von Willebrand disease (AVWS), platelet-type VWD, inherited platelet disorders, etc.\]; or significantly abnormal coagulation parameters due to diseases other than von Willebrand disease (e.g., platelet disorders, vitamin K deficiency, etc.);
• •6. Presence of protein C deficiency or protein S deficiency;
• •7. History of thrombosis or family history of thrombosis prior to signing informed consent or currently, or history of thrombophilia;
• •8. Severe bleeding due to VWD within 2 years prior to screening, such as intracranial hemorrhage, esophageal variceal bleeding, etc.;
• •9. Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association class \>= III), severe arrhythmia (QTc interval \> 500 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg), etc.;
• •10. Female patients with menstrual abnormalities due to organic gynecological diseases (e.g., uterine fibroids, endometriosis, adenomyosis, etc.);
• •11. Previous or current life-threatening malignant neoplasms or end-stage liver disease;
• •12. Use of DDAVP or plasma-derived VWF-containing factor VIII concentrate, plasma-derived/recombinant VWF preparations, or antifibrinolytic therapy within 1 week prior to the first dose;
• •13. Use of antithrombotic agents within 1 week prior to the first dose;
• •14. Receipt of fresh blood/plasma or cryoprecipitate therapy within 2 weeks prior to the first dose;
• •15. Receipt of vaccination within 1 month prior to the first dose or planned vaccination during the study period;
• •16. Major surgery (major surgery defined as Grade III and IV surgeries) within 1 month prior to the first dose, or planned surgery during the study period;
• •17. Enrollment in other clinical trials within 1 month prior to the first dose;
• •18. History of drug abuse or alcohol dependence (alcohol dependence criteria: long-term drinking history exceeding 5 years, equivalent ethanol intake \>= 40 g/day, or heavy drinking within 2 weeks, equivalent ethanol intake \> 80 g/day. Ethanol amount (g) conversion formula = alcohol consumption (mL) x alcohol content (%) x 0.8);
• •19. Presence of psychiatric disease or significant mental disorder, or other reasons resulting in incapacity or lack of cognitive ability;
• •20. Plans for procreation or sperm donation throughout the study period up to 3 months after the last dose, or unwillingness to use effective physical contraceptive measures (e.g., condoms);
• •21. Presence of clinically significant disease or other reasons rendering the patient unsuitable for clinical trial participation in the investigator's opinion (e.g., patient unlikely to benefit from the clinical trial);
• •22. Patients whom the investigator considers to have poor compliance, rendering efficacy evaluation difficult or likelihood of completing the planned treatment course and follow-up low.