The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
300 milligrams (mg) subcutaneous injection marstacimab PFP
300 mg subcutaneous injection of marstacimab PFS
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, Belgium
Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf)
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Area under the concentration time curve from time 0 to time of last quatifiable concenteration
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Time for Cmax
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Apparent clearance after subcutaneous dose
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Apparent volume of distribution after subcutaneous dose
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Terminal half-life after subcutaneous dose
Time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose
Incidence of clinically significant laboratory value abnormalities
Time frame: Baseline through the end of study, approximately 161 days
Incidence of anti-drug antibody against marstacimab
Time frame: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
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Incidence of Adverse Events
Time frame: Baseline through the end of study, approximately 161 days
Incidence of neutralizing antibody against marstacimab
Time frame: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days
Incidence of Serious Adverse Events
Time frame: Baseline through the end of study, approximately 161 days