Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Study Overview
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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.

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

Conditions
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Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Intervention / Treatment
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* Drug: catridecacog
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rFXIII<br> | Drug: catridecacog<br>* 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).<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Days 0-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |