Conditions: Congenital Bleeding Disorder Healthy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: vatreptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: placebo intervention 6: placebo intervention 7: placebo intervention 8: placebo
Intervention descriptions: intervention 1: One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg intervention 2: One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg intervention 3: One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg intervention 4: One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg intervention 5: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg intervention 6: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg intervention 7: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg intervention 8: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Protocol document: