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

ConditionVon Willebrand Diseases
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • VGA039

    Drug

    Single doses of VGA039

  • Placebo

    Other intervention

    Single doses of Placebo

  • VGA039

    Drug

    Multiple doses of VGA039

Treatment groups

116 Participants
are divided into 5 treatment groups
Group A: Part 1Placebo comparator 2 interventions
Group B: Part 2Experimental treatment 1 intervention
Group C: Part 3Experimental treatment 1 intervention
Group D: Part 4Experimental treatment 1 intervention
Group E: Part 5Experimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]

Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).

Time frame
From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively

Secondary outcomes

1

Plasma Concentrations of single IV and SC doses of VGA039

Time frame
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
2

Pharmacodynamics of single IV and SC doses of VGA039

Time frame
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
3

Incidence of Anti-drug antibodies to VGA039

Time frame
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vega Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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