drugset / Trial / NCT05762276
A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Administered IM in Adult Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VXX-401 | Peptide | 100 ug | Intramuscular |
| Subject | VXX-401 | Peptide | 300 ug | Intramuscular |