Healthy
Conditions
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.
Interventions
BIOLOGICALrVIIa-FP
Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
BIOLOGICALPlacebo (0.9% normal saline)
Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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®).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP | 120 hours |
| Clearance (Cl) 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 |
Countries
Germany
Outcome results
None listed