A Phase 1/2 interventional study of ENP-501 and Placebo in Peanut Allergy, sponsored by N-Fold, LLC. Recruiting at 1 site in United States. Open to participants aged 14 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by N-Fold, LLC · Phase 1/2, Interventional, and Treatment
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)
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 68 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →This is the only study on the registry with N-Fold, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1:
Part 1 Cohort 1 only (NPA Participants)
Part 1 Cohort 2 only (PA Participants)
At least two of the three following requirements:
Part 2:
At least two of the three following requirements at screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ENP-501
Drug: Placebo
* 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
* 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
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: 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
Time frame: Up to 22 Weeks
Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Physical Examination in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Vital Signs in Part 1
Time frame: 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
Time frame: Up to 72 Weeks
Number of Participants Able to Tolerate 2000 µg Dose of ENP-501 Without Experiencing Dose-Limiting Toxicity (DLT) in Part 1
Time frame: Up to 22 Weeks
Change in Total IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 72 Weeks
Maximum Severity of Symptoms Occurring at Each Challenge Dose of Peanut Protein During the Exit DBPCFC in Part 2
Time frame: Up to 72 Weeks
Number of Participants Able to Tolerate the 2000 µg Dose of ENP-501 in Part 2
Time frame: Up to 72 Weeks
Change in Total IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 2
Time frame: 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
Time frame: 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
Time frame: Up to 72 Weeks
Number of Participants with TEAEs leading to discontinuation as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Physical Examination in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Vital Signs in Part 2
Time frame: Up to 72 Weeks
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