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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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.
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.
Phase I Unit
Berlin, Germany
The frequency of related Adverse Events (AEs) to rVIIa-FP.
Time frame: 28 days
Number of subjects who develop inhibitors against Factor VII (FVII).
Time frame: 28 days
Number of subjects who develop antibodies against rVIIa-FP.
Time frame: 28 days
Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP
Time frame: 120 hours
Half- life (t1/2) of a single dose of rVIIa-FP
Time frame: 120 hours
Incremental recovery (IR) of rVIIa-FP
Time frame: 120 hours
Clearance (Cl) of a single dose of rVIIa-FP
Time frame: 120 hours
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