The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.

Inclusion Criteria:

1. Male ≥18 years and ≤65years of age;

2. Confirmed diagnosis of hemophilia A, and endogenous FVIII ≤2%:

3. <1% (<1 IU/dL) endogenous FVIII activity levels as historically documented by acertified laboratory or screening data results; OR

4. 1%-2% (1-2 IU/dL) endogenous FVIII activity levels and >10 bleeding events peryear (in the last 52 weeks prior to screening); OR

5. 1%-2% (1-2 IU/dL) endogenous FVIII activity levels and on prophylaxis;

6. Have had ≥150 prior exposure days (EDs) to any recombinant and/or plasma-derivedFVIII protein products.

7. Agree to use reliable barrier contraception and prohibition of sperm donation until 52 weeks after the administration of ZS802.

8. Subjects voluntarily participate and are fully informed, fully understand theresearch and can comply with the requirements of the research protocol, are willingto complete the research as planned, and voluntarily cooperate with the provision ofbiological samples for testing.

Exclusion Criteria:

1. Hypersensitivity to any component of the study drug (including immunosuppressants)or a condition that can not use.

2. Inability to tolerate immunosuppressants or steroid drugs.

3. Have no measurable FVIII inhibitor as assessed by laboratory; or documented no priorhistory of FVIII inhibitor.

4. Who have a history or are currently suffering from any of the following seriousclinical diseases:

5. History of malignancy or current presence of any malignancy;

6. Have active autoimmune disease;

7. Severe heart disease, including angina pectoris, myocardial infarction, heartfailure, clinically significant congenital heart disease, heart valve disease,arrhythmia and atrioventricular block, etc.;

8. Have underlying liver disease or history of liver disease (such as portalhypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathyor hepatic fibrosis);

9. Have active hepatitis B infection (HBsAg positive or HBV-DNA positive) oractive hepatitis C infection (HCVAb positive), or are currently receivinghepatitis B or hepatitis C antiviral therapy;

10. Have history of chronic infection or other chronic disease that theInvestigator considers to constitute an unacceptable risk;

11. Diabetes mellitus that is poorly controlled after drug treatment;

12. Uncontrolled hypertension or hypotension;

13. laboratory values:

14. Hemoglobin<110g/L;

15. Platelets<100×10^9/L;

16. AST, ALT, alkaline phosphatase>2×ULN;

17. Total bilirubin>1.5×ULN;

18. Creatinine>ULN;

19. Albumin<LLN;

20. HIV antibody positive or Treponema pallidum antibody positive.

21. Have AAV5 capsid neutralizing antibody titers >1:5.

22. Those who have received clinical trials of gene therapy before screening, or haveused FVIII clinical trial drugs within 1 month, or participated in other drug/deviceclinical trials within 3 months, or plan to participate in other clinical trialsduring this study.

23. Those who have planned surgery within 52 weeks after the infusion.

24. Those who donated or lost more than 400 mL of blood within 3 months beforescreening.

25. Those with epilepsy, history of mental illness (such as schizophrenia, depression,mania or anxiety) or obvious mental disorder, incapacitated or incapacitated byother reasons.

26. Patients with a history of drug abuse or alcoholism.

27. Investigators believe that subjects have poor compliance or are expected to be lesslikely to complete follow-up.

28. There are clinically significant diseases or other reasons that the researcherand/or collaborators consider unsuitable to participate in this researcher.