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

NCT07117669 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • CBCC Global Research

    collaborator NETWORK

  • N-Fold, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117669 on ClinicalTrials.gov