Safety and Pharmacokinetics of Recombinant Factor XIII Administration 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 multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Official Title
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A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration 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 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

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>* 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).<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Days 0-33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |