Pharmacokinetics of rFVIIIFc at Two Vial Strengths

Exclusion Criteria

• •Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
• •Previous treatment with rFVIIIFc as study drug or commercial product.
• •Other coagulation disorder(s) in addition to hemophilia A.
• •History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
• •Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
• •Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.