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

NCT07117669 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ENP-501-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peanut Hypersensitivity

Outcome Measures

Primary Outcomes (8)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1

  Up to 22 Weeks

• Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 1

  Up to 22 Weeks

• Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1

  Up to 22 Weeks

• Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1

  Up to 22 Weeks

• Number of Participants with changes in Clinical Laboratory Values in Part 1

  Up to 22 Weeks

• Number of Participants with changes in Physical Examination in Part 1

  Up to 22 Weeks

• Number of Participants with changes in Vital Signs in Part 1

  Up to 22 Weeks

• Proportion of Participants Tolerating ≥1043 mg Cumulative Peanut Protein Without Dose-Limiting Symptoms at End of Treatment (EOT) Visit Double-Blind Placebo-Controlled Food Challenge (DBPCFC) Compared to Placebo in Part 2

  Up to 72 Weeks

Secondary Outcomes (29)

• Number of Participants Able to Tolerate 2000 µg Dose of ENP-501 Without Experiencing Dose-Limiting Toxicity (DLT) in Part 1

  Up to 22 Weeks

• Change in Total IgE Levels in Part 1

  Screening and Week 22 (EOS)

• Change in Ara h 1-Specific IgE Levels in Part 1

  Screening and Week 22 (EOS)

• Change in Ara h 2-Specific IgE Levels in Part 1

  Screening and Week 22 (EOS)

• Change in Ara h 3-Specific IgE Levels in Part 1

  Screening and Week 22 (EOS)

Study Arms (2)

ENP-501

EXPERIMENTAL

Drug: ENP-501

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ENP-501 DRUG

* 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

ENP-501

Placebo DRUG

* 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

Placebo

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Part 1:
• 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
• Negative Skin Prick Test (SPT) (wheal diameter of \<3 mm) to peanut
• Part 1 Cohort 2 only (PA Participants)
• A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
• At least two of the three following requirements:
• Positive Skin Prick Test (SPT) (wheal diameter of ≥ 8 mm) to peanut

You may not qualify if:

• 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
• Use of any food allergen-specific or other non-traditional form of allergen immunotherapy within one year of Screening
• Use of immunosuppressive drugs within 30 days of Screening
• Use of ß-blockers (oral)
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
• Pregnant or breast-feeding (if female)

Sponsors & Collaborators

• N-Fold, LLC: lead
• CBCC Global Research: collaborator

Study Sites (1)

Research Site 001

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Balraj Sangha

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 12, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)