Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Congenital FXIII Deficiency

Congenital Bleeding Disorder

Treatments

Drug: catridecacog

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01848002

F13-1662

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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