- Male patients at least 18 years old with severe or moderately severe hemophilia A
(facto VIII concentration less than or equal to 2%).
- Negative test for facto VIII inhibitor.
- If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
- Ability to abstain from use of FVIII products for 72 hours at a time.
- History of any positive test result for factor VIII inhibitor.
- Presence of any bleeding disorder in addition to Hemophilia A.
- Body weight less than 50 kg.
- History of alcoholism.
- Treatment with investigational drug or device within 30 days prior to the Screening