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

CSL Behring

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: rVIIa-FP

Biological: Placebo (0.9% normal saline)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01542619

2011-004568-32 (EudraCT Number)

CSL689_1001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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®).