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Clinical Trial NCT05776069

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.

  • ClinicalTrials.gov ID: NCT05776069
  • Not accepting healthy volunteers
  • UTSW Principal Investigator: AYESHA NOOR ZIA

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.

objective

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

If you are interested in this clinical trial, please contact Kendra Malone on the Children’s Health Research Team.Call 214-456-3359Email