NCT05476497

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Allergy Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	VLP Peanut	solution for subcutaneous administration
BIOLOGICAL	Placebo	solution for subcutaneous administration
BIOLOGICAL	VLP Peanut	solution for Skin-prick testing

Timeline

• Start date: 2022-10-17
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-07-27
• Last updated: 2026-03-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study