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

Prior treatment

• Use of emicizumab within less than 6 months before the date of signing the ICF.
• Presence of AAV6 antibodies detected by ELISA.

Other illness

• History of use of any gene therapy product.
• The presence of other blood or hematopoietic disorders other than hemophilia A.
• Diagnosis of HIV infection.
• HBV infection.
• HCV infection.
• Any active systemic infections or recurrent infections requiring systemic therapy at screening.
• Any other disorders associated with severe immunodeficiency.
• Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder.
• Malignancies with remission duration of less than 5 years at the time of signing the ICF, except for cured basal cell carcinoma.

Other

• BMI \<16 kg/m² or ≥35 kg/m².

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