Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

Inclusion criteria

• Body weight between 50.0 and 100.0 kg, both inclusive
• Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive

Exclusion criteria

• Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
• Any clinical sign or known history of atherosclerosis or thromboembolic events
• Renal dysfunction
• A subject considered at high risk of thromboembolic events
• Overt bleeding, including from gastrointestinal tract
• Hepatitis B or C infection
• Human immunodeficiency virus (HIV) infection
• Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
• Smoking within 3 months prior to trial start
• Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
• Excessive consumption of a diet deviating from a normal diet
• Blood donation within the last three months prior to screening
• The receipt of any investigational product within 30 days of trial product administration
• Participation in any other trial investigating a procoagulant within the last six months prior to screening
• Strenuous exercise within four days prior trial start
• Suffers from a life threatening disease
• Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
• Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
• Subjects with high fasting cholesterol at trial start