A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A

Inclusion Criteria:

1. Male subjects aged ≥18 years at the time of signing the informed consent form.
2. Established diagnosis of hemophilia A with a documented history of endogenous FVIIIactivity ≤1% AND ≤2% at screening.
3. Therapy with FVIII concentrates for at least 150 exposure days.

Exclusion Criteria:

1. History of use of any gene therapy product.
2. Use of emicizumab within less than 6 months before the date of signing the ICF.
3. The presence of other blood or hematopoietic disorders other than hemophilia A.
4. Presence of AAV6 antibodies detected by ELISA.
5. BMI <16 kg/m² or ≥35 kg/m².
6. Diagnosis of HIV infection.
7. HBV infection.
8. HCV infection.
9. Any active systemic infections or recurrent infections requiring systemic therapy atscreening.
10. Any other disorders associated with severe immunodeficiency.
11. Relevant hepatic disorders or conditions that can be a symptom of existing liverdisorder.
12. Malignancies with remission duration of less than 5 years at the time of signing theICF, except for cured basal cell carcinoma.