Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Congenital FXIII Deficiency; Congenital Bleeding Disorder

Treatments: Drug: placebo; Drug: catridecacog

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847989

F13-1661

Details and patient eligibility

About

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

Enrollment: 50 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

rFXIII

Experimental group

Treatment:

Drug: catridecacog

Placebo

Placebo Comparator group

Treatment:

Drug: placebo