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NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT07117669•N-Fold, LLC

View on ClinicalTrials.gov

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)

Eligibility

Age

14 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1:
•14-50 years of age (inclusive)
•Otherwise medically healthy and able to participate in the study
•Able to perform spirometry testing in accordance with the American Thoracic Society (ATS) guidelines (2019)
•All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product
•Signed and dated written informed consent from the participant and/or parent or guardian
•Signed and dated assent from participant under 18 in accordance with local IRB regulations
•Willing and able to avoid peanut and peanut contaminants for the duration of the trial
•Part 1 Cohort 1 only (NPA Participants)
•No known clinical history of peanut allergy with regular exposure to peanuts in daily life, i.e ingests peanuts without symptoms
+21 more criteria

Exclusion Criteria

•History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs
•Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF \>/= 450 msec at Screening
•FEV1 value \< 80% predicted at Screening
•Any hospitalization in the past year for asthma, \>1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma
•Poorly controlled atopic dermatitis
•Eosinophilic gastrointestinal disease
•Use of oral or IV corticosteroids within 30 days of Screening
•Use of tricyclic antidepressants within 6 months of Screening
•Inability to discontinue antihistamines for at least 5 half-lives before skin testing
•Use of omalizumab or other immunomodulatory therapy (not including corticosteroids) or biologic therapy within one year of Screening
+9 more criteria

Locations (1)

Research Site 001

Aurora, Colorado, United States

Key Dates

Start Date

August 1, 2025

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2028

Last Updated

August 21, 2025

Enrollment

ESTIMATED participants

Conditions

Peanut Allergy

Interventions

ENP-501

DRUG

Placebo

DRUG

Contacts

Balraj Sangha

CONTACT

+1 (661) 322-2206 balraj.sangha@cbcc.global

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

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