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:
INCLUSION 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.
EXCLUSION CRITERIA
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.

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
Contition
Von Willebrand Diseases
Age (in years)
18 - 60
Phase
Phase 1
Participants needed
64
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Vega Therapeutics, Inc
ClinicalTrials.gov identifier
NCT05776069
Study number
VGA039-CP001
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?