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Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

NCT01847989•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Novo Nordisk Investigational Site

Berkshire, United Kingdom

Key Dates

Start Date

January 1, 2003

Primary Completion Date

May 1, 2003

Completion Date

May 1, 2003

Last Updated

January 11, 2017

Enrollment

ACTUAL participants

Conditions

Congenital Bleeding DisorderCongenital FXIII DeficiencyHealthy

Interventions

catridecacog

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

A New Portable Device for Non-invasive Ventilatory Support

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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