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