Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy
• Interventions: Drug: placebo; Drug: catridecacog

• Registration Number: NCT01847989
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
rFXIII	catridecacog	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Days 0-28

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements	Days 0-28
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)	Days 0-28
Incidence of yeast antibodies	Days 0-28

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Berkshire, United Kingdom