Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 to 60

Critères de participation

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.