Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Inclusion Criteria: * Normal platelet count and clotting parameters * Adequate renal and hepatic function * If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit * If a sexually active male or a sexually active female 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 * Negative drug and 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 * Any surgical procedure in the 30 days prior to enrollment * Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus * Receipt of treatment with any experimental agent within 30 days of study enrollment