Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

This is an interventional treatment trial for Acquired Bleeding Disorder Read More

Inclusion Criteria:

• Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
• Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)

Exclusion Criteria:

• The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
• Known or suspected allergy to yeast
• Known bleeding or hematologic disorder
• Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
• Smoking more than 10 cigarettes/day or equivalent
• Not able or willing to refrain from smoking whenever required for the trial procedures
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the physician
• Excessive consumption of a diet deviating from a normal diet as judged by the physician
• Strenuous exercise as judged by the physician within 4 days prior to trial start (screening)
• Surgery or trauma with significant blood loss (500 mL or more blood) within 3 months prior to trial start (screening)
• Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods. Adequate contraceptive measures include that the subject uses a condom during intercourse or that the partner practices adequate conception (sterilisation, hormonal intrauterine devices and oral contraceptives).