Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Congenital FXIII Deficiency Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rFXIII

Group Type EXPERIMENTAL

catridecacog

Intervention Type DRUG

Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Interventions

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catridecacog

Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Intervention Type DRUG

placebo

Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes