Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Inclusion Criteria:

• Normal platelet count and clotting parameters
• Adequate renal and hepatic function
• Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and of child-bearing potential)
• Agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits (if subject a sexually active male or female of childbearing potential)
• Negative drug and negative alcohol screens

Exclusion Criteria:

• Known antibodies or hypersensitivity to FXIII
• Known bleeding or hematologic disorder
• Known allergy to yeast
• Receipt of blood products within 30 days of screening
• Donation of blood within 30 days prior to enrollment
• Surgical procedure of any type within 30 days prior to enrollment
• History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
• Treatment with any experimental agent within 30 days of study enrollment