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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-60
SponsorVega Therapeutics, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • VGA039
  • Placebo
  • VGA039

Treatment groups

116 Participants
are divided into 5 treatment groups

Sponsors and collaborators