VGA039 for Von Willebrand Disease

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Vega Therapeutics, Inc

Trial Summary

What is the purpose of this trial?This trial tests VGA039, a new drug, in healthy people and those with Von Willebrand disease. The goal is to see if it is safe and how it behaves in the body when injected. Participants will be monitored for a period of time after receiving the drug.

Eligibility Criteria

This trial is for adults aged 18-60 who are generally healthy or have Von Willebrand Disease (VWD) with a history of bleeding or bruising. Healthy participants must have normal lab results and vital signs, while those with VWD need hemoglobin levels ≥ 8 g/dL and platelet count ≥ 150 × 109/L. People using hormonal contraceptives recently or with certain blood disorders can't join.

Inclusion Criteria

Additional important requirements for participants in the second part of the study.

I have Von Willebrand Disease and experience bleeding or bruising.

I have not used hormonal contraceptives in the last 56 days.

+7 more

Participant Groups

The study tests VGA039's safety and effects when given once via IV or SC to healthy volunteers and VWD patients. It's a Phase 1a trial, meaning it's an early-stage study focusing on how the drug behaves in the body (pharmacokinetics) and its impact on the disease (pharmacodynamics).

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 5Experimental Treatment0 Interventions

Multiple doses of VGA039 in open label extension

Group II: Part 4Experimental Treatment1 Intervention

Cohorts of VGA039 single dose for surgical prophylaxis

Group III: Part 3Experimental Treatment1 Intervention

Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined

Group IV: Part 2Experimental Treatment1 Intervention

Cohorts A-H IV or SC VGA039 dose to be determined

Group V: Part 1Placebo Group2 Interventions