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ACTIVE NOT RECRUITING
NCT05476497
PHASE1

Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects

Sponsor: Allergy Therapeutics

View on ClinicalTrials.gov

Summary

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT)

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2022-10-17

Completion Date

2026-11

Last Updated

2026-03-13

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

VLP Peanut

solution for subcutaneous administration

BIOLOGICAL

Placebo

solution for subcutaneous administration

BIOLOGICAL

VLP Peanut

solution for Skin-prick testing

Locations (10)

University of Arizona

Tucson, Arizona, United States

University of South Florida

Tampa, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Trio Clinical Trials, LLC.

Houston, Texas, United States

University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

Madison, Wisconsin, United States