Inclusion Criteria:
* Male ≥18 years of age
* Severe or moderately severe hemophilia A (FVIII activity ≤ 2 IU/dL) as evidenced by
* medical history
* Received FVIII prophylactic or on-demand replacement therapy for ≥ 150 accumulated
* days (exposure days)
* ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
* BMI ≤ 30
* Agree to use double-barrier contraceptive until at least 3 consecutive semen samples are negative after ASC-618 infusion
Exclusion Criteria:
* Pre-existing immunity to AAV8 vector as defined by AAV8 total antibodies and neutralizing antibodies qualified tests.
* Current inhibitors, or history of high titer FVIII inhibitors
* Presence of \> Grade 2 liver fibrosis on elastography/Fibroscan or comparable imaging methodology
* History of chronic renal disease
* Active infection or any immunosuppressive disorder
* History of cardiac surgery and need anticoagulant therapy
* Any cardiovascular / genetic risk factors for thromboembolic disorders
* Evidence of active Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)-1/2 or syphilis infection.
* Receipt of any vector or gene transfer agent
* Current antiviral therapy for hepatitis B or C
View Inclusion and Exclusion Criteria at ClinicalTrials.gov