Peanut AllergyPhase 1/2NCT07117669
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
A Phase 1/2 study testing ENP-501 in people with Peanut Allergy, run by N-Fold, LLC at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- ENP-501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to Nov 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
- An elevated serum peanut specific IgE level ≥ 7 kUA/L (ImmunoCAP®)
- An Ara-h2 IgE level of ≥ 2 kUA/L (ImmunoCAP®)
- Part 2:
- 14 to 50 years of age (inclusive)
- 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 at screening:
- Positive SPT (wheal diameter of ≥ 3 mm) to peanut
- Serum peanut-specific IgE level ≥ 0.7 kUA/L (ImmunoCAP®)
- An Ara-h2 IgE level of ≥ 0.5 kUA/L (ImmunoCAP®) within 1 year of enrollment
- Participant must be willing and able to complete a DBPCFC at screening and EOT (24-hours after last dose) and experience dose-limiting symptoms at or before the 300 mg challenge dose of peanut protein during a Double Blind, Placebo Controlled Food Challenge (DBPCFC) conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines
- Otherwise medically healthy and able to participate in the study
- Able to perform spirometry testing in accordance with the 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
Who cannot join
- 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
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- 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)
- Behavioral, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the participant to understand and cooperate with the study protocol
- Known allergy to inactive ingredients of investigational product (active or placebo)
- Participation in another interventional clinical trial within 30 days of Screening or within 5 half-lives of the other IP
- Residing at the same address as another participant in this or any peanut immunotherapy study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Research Site 001
Aurora, Colorado, 80045
About this study
Official title: 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
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
- Being tested
- ENP-501, Placebo
- Keywords
- Peanut Hypersensitivity
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENP-501Drug
- 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
PlaceboDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| ENP-501 | Experimental | Not described Receives: Drug: ENP-501 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1
Measured: 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
Measured: Up to 22 Weeks
Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1
Measured: Up to 22 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1
Measured: Up to 22 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 1
Measured: Up to 22 Weeks
Number of Participants with changes in Physical Examination in Part 1
Measured: Up to 22 Weeks
Number of Participants with changes in Vital Signs in Part 1
Measured: 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
Measured: 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
Measured: Up to 22 Weeks
Change in Total IgE Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 1
Measured: Screening and Week 22 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 1
Measured: Screening and Week 22 (EOS)
Proportion of Participants Tolerating at Least 443 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Measured: Up to 72 Weeks
Proportion of Participants Tolerating at Least 2043 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Measured: Up to 72 Weeks
Proportion of Participants Tolerating 4043 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Measured: Up to 72 Weeks
Maximum Severity of Symptoms Occurring at Each Challenge Dose of Peanut Protein During the Exit DBPCFC in Part 2
Measured: Up to 72 Weeks
Number of Participants Able to Tolerate the 2000 µg Dose of ENP-501 in Part 2
Measured: Up to 72 Weeks
Change in Total IgE Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 2
Measured: Screening and Week 72 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 2
Measured: Screening and Week 72 (EOS)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 2
Measured: Up to 72 Weeks
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 2
Measured: Up to 72 Weeks
Number of Participants with TEAEs leading to discontinuation as Assessed by NCI CTCAE v 5.0 in Part 2
Measured: Up to 72 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 2
Measured: Up to 72 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 2
Measured: Up to 72 Weeks
Number of Participants with changes in Physical Examination in Part 2
Measured: Up to 72 Weeks
Number of Participants with changes in Vital Signs in Part 2
Measured: Up to 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start16 Dec 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N-Fold, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117669
- Sponsor's protocol ID
- ENP-501-001
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No