Healthy

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

NCT01542619 | PHASE 1 | INTERVENTIONAL

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.

1 Sites

40 Participants

Recruiting

18 Years to 35 Years

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SUBMIT

Phase I Unit

Berlin,Germany

Study 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®).

Additional Studies

Additional studies can be found at ClinicalTrials.gov