NCT07117669

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ENP-501 in Non-Peanut Allergic Participants and Participants With a Known Peanut Allergy

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: N-Fold, LLC · Industry
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and participants with an established peanut allergy (PA)

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	ENP-501	* Part 1: Participants will receive buccal administrations of ENP-501 daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of ENP-501 daily for 52 weeks following achieving the 2000 µg target dose
DRUG	Placebo	* Part 1: Participants will receive buccal administrations of placebo daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of placebo daily for 52 weeks following achieving the 2000 µg target dose

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-08-12
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study