VGA039-CP001, A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of VGA039 Following Intravenous or Subcutaneous Administration of Single Ascending Doses in Healthy Adults and Adult Patients with von Willebrand Disease.
Study ID: STU-2023-0787
Summary
This is a multi-center, Phase 1a study to assess the safety, tolerability, PK, and PD of VGA039 following single IV or SC dose administration in healthy subjects and subjects with VWD.
The primary and secondary objectives are as follows: 1. To investigate the safety and tolerability of single intravenous (IV) or subcutaneous (SC) doses of VGA039 2. To investigate the pharmacokinetics (PK) of single IV or SC doses of VGA039 3. To investigate the pharmacodynamics (PD) of single IV or SC doses of VGA039 4. To investigate the presence of anti-drug antibodies (ADAs) raised against VGA039 after single IV or SC doses
