Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

Inclusion Criteria:

• Caucasian or Japanese
• Healthy as defined by medical history, physical and biological examinations

Exclusion Criteria:

• History of allergy or hypersensitivity reaction to any medication
• History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
• Alcohol or substance abuse disorder
• Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health