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

Phase 1
Completed
Conditions
Healthy
Interventions
Biological: rVIIa-FP
Biological: Placebo (0.9% normal saline)
Registration Number
NCT01542619
Lead Sponsor
CSL Behring
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
40
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.
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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®).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
rVIIa-FPrVIIa-FP-
Placebo (0.9% normal saline)Placebo (0.9% normal saline)-
Primary Outcome Measures
NameTimeMethod
The frequency of related Adverse Events (AEs) to rVIIa-FP.28 days
Number of subjects who develop inhibitors against Factor VII (FVII).28 days
Number of subjects who develop antibodies against rVIIa-FP.28 days
Secondary Outcome Measures
NameTimeMethod
Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP120 hours
Half- life (t1/2) of a single dose of rVIIa-FP120 hours
Incremental recovery (IR) of rVIIa-FP120 hours
Clearance (Cl) of a single dose of rVIIa-FP120 hours

Trial Locations

Locations (1)

Phase I Unit

🇩🇪

Berlin, Germany

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