This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
Unnamed facility
Warsaw, Poland
Unnamed facility
Bloemfontein, Freestate, South Africa
Unnamed facility
Johannesburg, Gauteng, South Africa
Unnamed facility
London, United Kingdom
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to Day 50
Pharmacokinetic assessment, based on plasma concentration of BAY86-6150
Time frame: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
Pharmacodynamic assessment, based on plasma hemostasis marker level
Time frame: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels
Time frame: 3 time points from pre-dosing on Day 1 up to Day 50
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.