A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers

A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers

This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

Inclusion Criteria:

• Healthy male subjects between 18 and 35 years of age, both inclusive.
• Body weight between 50.0 and 100.0 kg, both inclusive.
• Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
• Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

• Subjects at increased cardiovascular risk.
• Any clinical sign or known history of atherosclerosis or thromboembolic events.
• A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
• Subjects with significant elevation of cholesterol level.
• Renal dysfunction.
• Overt bleeding.
• Smokers with positive cotinine test at screening.
• Participation in any other trial investigating a procoagulant within the last six months prior to screening.
• Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
• Contraindications to Warfarin (Coumadin®).