For Healthcare Professionals

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


About the study

This is a multi-center, Phase 1a study to assess the safety, tolerability, PK, and PD of VGA039 following single IV or SC dose administration in healthy subjects and Von Willebrand disease patients.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria (All Subjects)

  1. Subjects, 18 to 60 years of age, inclusive.
  2. 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)

  1. Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
  2. Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.

Exclusion Key Criteria (All Subjects)

  1. Use of hormonal contraceptives within 56 days prior to administration of the study drug.
  2. Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
  3. Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
  4. History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
  5. 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)

  1. Baseline FVIII activity > 50 IU/dL.
  2. Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Von Willebrand Diseases

Age (in years)

18 - 60


Phase 1

Participants needed


Est. Completion Date

Dec 31, 2024

Treatment type



Vega Therapeutics, Inc identifier


Study number


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