Evaluation of VGA039 Treatment in Healthy Volunteers and Patients with Von Willebrand Disease and Other Bleeding Disorders

What this Trial Is About

Researchers are evaluating VGA039 in a study called VIVID, which involves healthy volunteers and people with von Willebrand Disease VWD and other bleeding disorders. This study is designed in multiple parts to assess the safety, tolerability, and effects of intravenous IV and subcutaneous SC forms of VGA039. The study includes both single and multiple-dose evaluations and covers early phase 1 and phase 2 research. The study has five parts Part 1 tests single ascending doses of IV or SC VGA039 or placebo in healthy volunteers with random assignment and masking. Part 2 involves open-label single ascending doses in people diagnosed with VWD. Part 3 studies multiple doses of SC VGA039 in VWD patients. Part 4 evaluates single doses given before minor surgery in VWD subjects. Part 5 is an open-label extension of multiple doses in eligible VWD patients who previously participated in VGA039 trials. Participants receive doses and are followed for 8 to 15 weeks depending on the administration route. Participants attend study visits for treatment, monitoring, and follow-up over several weeks. Researchers will assess safety by tracking treatment-emergent adverse events and measure drug levels in the blood and immune responses. Laboratory tests, vital signs, and ECGs are conducted to monitor health. The total duration of follow-up ranges from 8 weeks for SC dosing to 15 weeks for IV dosing. This study aims to provide important information on how VGA039 behaves in the body and its safety profile in both healthy and affected individuals.

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