A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

The primary objectives of the study are to evaluate the Pharmacokinetics，Safety and tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in patients with severe hemophilia A.

The secondary objectives are to monitor anti-durg antibodies and anti-PEG antibodies levels in patients with severe hemophilia A


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically confirmed hemophilia A (coagulation factor VIII \<1%) and previous medical records confirming exposure to coagulation factor VIII for ≥150 days (EDs ≥150).
* Non-immunodeficient, with some immunity (CD4 \> 200/μL).
* Platelet count \>100×10\^9/L.
* Normal prothrombin time (PT) or international normalized ratio (INR) \<1.3.
* Negative lupus anticoagulant.
* Fully understand, informed about this study and sign the informed consent form, voluntarily participate in the clinical study and have the ability to complete all study procedures

Exclusion Criteria:

* Hypersensitivity to the test substance or its excipients (including rodent or hamster protein).
* Pre-existing hypersensitivity or allergic reactions to FVIII or IgG2 injection therapy.
* Positive FVIII inhibitor at screening (≥0.6 BU/mL), or previous history of FVIII inhibitor Positive history, or family history of inhibitors.
* Patients with other coagulation disorders in addition to hemophilia A.
* The results of vWF antigen examination lower than normal.
* Severe anemia and need blood transfusion (hemoglobin \< 60g/L).
* Patients who have received any standard half-lives FVIII formulations (e.g., Kogenate, Kovaltry, Advate, Xyntha, etc.) or received any other half-life-extending FVIII formulations within 4 days or 5 half-lives (whichever is longer) before administration.
* Patients who had used emecizumab within 6 months prior to administration.
* Patients with fever, upper respiratory tract infection or allergy symptoms within the previous 2 weeks before screening.
* Suffer from other diseases that may increase the risk of bleeding or the risk of thrombosis.
* Severe cardiovascular and cerebrovascular diseases: such as cerebral hemorrhage, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure(the current New York Heart Association cardiac function grade III, Hypertension that cannot be controlled with drug treatment: systolic blood pressure\> 160 mmHg or diastolic blood pressure\> 95 mmHg.
* Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
* Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 3 × upper limit of normal (ULN)).
* Abnormal kidney function: BUN \> 2×ULN, Cr \> 2.0mg/dL.
* One or more clinically significant tests for Hepatitis B Virus Surface Antigen, Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
* Patients who received any anticoagulant or antiplatelet therapy within a week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
* Systemic immunomodulators (e.g., corticosteroids \[equivalent dose of 10 mg/ day prednisone\], A-interferon, immunoglobulin, cyclophosphamide, cyclosporine, etc.) were used within 14 days prior to administration or during the study period.
* Patients having major surgery or receiving blood or blood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
* Patients who previously participated in the other clinical trials within a month prior screening.
* Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
* Patient who is considered by the other investigators not suitable for clinical study.