Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) 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