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A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Compared With Placebo in Adult Participants - Trial NCT05762276

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.

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NCT05762276
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05762276
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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

Study Focus

Hypercholesterolemia

VXX-401

Interventional

drug

Sponsor & Location

Vaxxinity, Inc.

Brookvale,Miranda,Sydney,Morayfield,Melbourne, Australia

Timeline & Enrollment

Phase 1

Mar 07, 2023

Apr 03, 2024

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 hypercholesterolaemia
Lipoprotein deficiency
Hyperglycaemia, unspecified
Disorders of lipoprotein metabolism and other lipidaemias
Other disorders of lipoprotein metabolism

Data Source

ClinicalTrials.gov

NCT05762276

Non-Device Trial