A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy

Inclusion Criteria: 1. Male age 20 to 65 years, inclusive 2. Diagnosis of Hemophilia A or B 3. Clinical diagnosis of hemophilic arthropathy in the knee(s) for at least 6 months 4. Pettersson score (based on X-ray) of 0 to 4 in at least one knee within 1 year of screening 5. IPSG (2012) overall score of 3 to 9 (based on MRI) in at least one knee at screening 6. Is able to read, understand, and sign the Informed Consent Form (ICF), communicate with the investigator, complete study diaries, and understand and comply with protocol requirements Exclusion Criteria: 1. Total knee replacement in the primary knee 2. Presence of joint infections in the primary knee 3. Knee surgery within 6 months prior to screening in the primary knee 4. Intra-articular hyaluronic acid (IAHA) or platelet-rich plasma (PRP) injection in the primary knee within 6 months prior to screening 5. Use of any of the following medications after the screening visit: 1. NSAID injection (oral NSAIDs including COX-2 inhibitors allowed) 2. Glucosamine or chondroitin 6. History of high responder inhibitory antibodies to factor VIII or factor IX clotting factor, with titer \>5 Bethesda units (BU), OR clinical evidence for presence of factor inhibitor 7. History of rheumatoid arthritis or gouty arthropathy 8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration \>2x the upper limit of laboratory normal range (ULN), or bilirubin \>1.5x ULN at screening 9. Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or TB