A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
Vega Therapeutics, Inc
Summary
The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.
Description
This first-in-human study consists of 5 parts based on the subject population. Part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to 8 cohorts in healthy volunteers. Part 2 is an open-label, SAD of SC or IV VGA039 in up to 8 cohorts in subjects diagnosed with VWD. All participants will be enrolled, treated, and followed up for 15 weeks (IV SAD) or 8 weeks(SC SAD). Part 3 is an open-label, Phase 1b study of SC multiple doses (MD) of VGA039 in up to 4 cohorts. Part 4 is an open-label, Phase 2 study of SC single, su…
Eligibility
- Age range
- 12–60 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria (All Subjects) * Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2 * Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5 * 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 Subj…
Interventions
- DrugVGA039
Single doses of VGA039
- OtherPlacebo
Single doses of Placebo
- DrugVGA039
Multiple doses of VGA039
Locations (25)
- Orthopedic Institute for Children (UCLA)Los Angeles, California
- UC Davis Medical CenterSacramento, California
- University of Colorado School of MedicineAurora, Colorado
- Hemophilia of Georgia Center for Bleeding & Clotting Disorders of EmoryAtlanta, Georgia
- Science 37, Inc.Morrisville, North Carolina
- Hemophilia Center of Western PAPittsburgh, Pennsylvania