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NCT05762276

A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Compared With Placebo in Adult Participants

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 in Healthy Adults
Vaxxinity, Inc.·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
VXX-401
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vaxxinity, Inc.
Location
Brookvale,Miranda,Sydney,Morayfield,Melbourne, Australia
Timeline & enrollment
Phase
Phase 1
Start date
Mar 07, 2023
End date
Apr 03, 2024
Enrollment
48 participants
Primary outcome

Frequency of adverse events,Immunogenicity,Immunogenicity

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.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05762276
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05762276 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vaxxinity, Inc. and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.