Primary Objective: -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay Secondary Objective: -To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
Duration of each part of the study for one participant: Total study duration: Up to 57 days. * Screening: up to 28 days. * Up to 29 days of safety observation following the IV BIVV001 dose administration (this period includes PK sampling up to the first 10 days following administration).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Pharmaceutical form:solution for injection Route of administration: intravenous injection
University of Iowa_Investigational Site Number :8400002
Iowa City, Iowa, United States
Hemophilia Center of Western Pennsylvania_Investigational Site Number :8400001
Pittsburgh, Pennsylvania, United States
Investigational Site Number :2500001
Lille, France
Investigational Site Number :2500002
Nantes, France
Pharmacokinetic Parameter: Maximum plasma concentration observed (Cmax)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Terminal half-life (t½z)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Total Clearance (CL)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Volume of distribution at steady state (Vss)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Area under the activity time curve extrapolated to infinity (AUC∞)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Mean residence time (MRT)
Time frame: Day 1 to Day 10
Pharmacokinetic Parameter: Incremental recovery (IR)
Time frame: Day 1 to Day 10
Number of participants with adverse events
Time frame: Up to Day 29
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