A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Inclusion Criteria:

• Caucasian origin
• Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
• Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

• Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
• Previous participation in this trial, defined as randomised to receive trial product
• Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
• Known history of atherosclerosis or thromboembolic events
• Overt bleeding, including from gastrointestinal tract
• Hepatitis B or C infection
• HIV infection
• Positive test for drugs of abuse