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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01848002

Enrollment

Registered

2013-05-07

Start date

2003-05-31

Completion date

2003-08-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Brief summary

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.

Interventions

DRUGcatridecacog

For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).

DRUGplacebo

For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	Days 0-33

Secondary

Measure	Time frame
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements	From days -1 through day 33
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)	From days -1 through day 33
Incidence of yeast antibodies	From days -1 through day 33

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026