Vanderbilt Clinical Trials

(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

(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.