Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease
Von Willebrand Diseases
About this trial
This is an interventional treatment trial for Von Willebrand Diseases focused on measuring Von Willebrand Disorder
Eligibility Criteria
Key Inclusion Criteria (All Subjects) Subjects, 18 to 60 years of age, inclusive. No clinically significant laboratory, ECG, or vital signs results. Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2 Additional Key Inclusion Criteria (for Subjects in Part 2 Only) Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising. Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening. Exclusion Key Criteria (All Subjects) Use of hormonal contraceptives within 56 days prior to administration of the study drug. Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening. Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation. History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction. Additional Key Exclusion Criterion (Subjects in Part 1 Only) • Baseline FVIII activity > 150 IU/dL. Additional Key Exclusion Criteria (Subjects in Part 2 Only) Baseline FVIII activity > 50 IU/dL. Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Part 1
Part 2
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
Cohorts A-H IV or SC VGA039 dose to be determined