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-FPBiological: 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
Group Intervention Description rVIIa-FP rVIIa-FP - Placebo (0.9% normal saline) Placebo (0.9% normal saline) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP 120 hours Half- life (t1/2) of a single dose of rVIIa-FP 120 hours Incremental recovery (IR) of rVIIa-FP 120 hours Clearance (Cl) of a single dose of rVIIa-FP 120 hours
Trial Locations
- Locations (1)
Phase I Unit
🇩🇪Berlin, Germany