drugset / Trial / NCT05762276

A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Administered IM in Adult Participants

NCT05762276 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This first-in-human (FIH) study of VXX-401, an anti-PCSK9 peptide-based immunotherapeutic candidate, is designed to assess the safety, tolerability, immunogenicity, and pharmacodynamics (PD) of VXX-401 and to determine an optimal dose regimen for LDL-C lowering in subsequent clinical trials.

Timeline

Start
2023-03-07
Primary completion
2024-06-27
Completion
2024-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject VXX-401 Peptide 100 ug Intramuscular
Subject VXX-401 Peptide 300 ug Intramuscular

Indications