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

Launched by CSL BEHRING · Feb 26, 2012

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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®).