Actively Recruiting
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study of ENP-501 in Participants With and Without Peanut Allergy
Led by N-Fold, LLC · Updated on 2026-04-24
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
N-Fold, LLC
Lead Sponsor
C
CBCC Global Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical activity of ENP-501 in people aged 14 to 50 years, including those who have a known peanut allergy and those who are not allergic to peanuts. This Phase 1/2 study includes healthy participants and aims to understand how ENP-501 might affect allergic reactions to peanut protein, an important concern for individuals with peanut allergy. Participants will receive daily buccal (inside the cheek) administrations of ENP-501 or a placebo. In Part 1 of the study, this treatment lasts for 6 to 14 weeks, and in Part 2, participants who reach a target dose of 2000 micrograms will continue treatment daily for 52 weeks. The study is randomized and includes dose escalation to assess safety and tolerability. During the study, participants will undergo regular assessments including monitoring for adverse events, changes in physical exams, vital signs, and laboratory tests. They will also complete specialized food challenges to measure their tolerance to peanut protein. The study will track immune responses through blood tests and skin prick tests over periods up to 72 weeks, helping researchers evaluate the treatment's impact and safety over time.
CONDITIONS
Brief Title
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 14 and 50 years
- Medically healthy and able to participate in the study
- Able to perform spirometry testing according to guidelines
- Women of child-bearing potential agree to abstain from sexual activity or use contraception during the study and for 30 days after last dose
- Signed informed consent and assent (if under 18) as required
- Willing and able to avoid peanut and peanut contaminants during the trial
- For non-peanut allergic group: no clinical history of peanut allergy and negative peanut skin prick test
- For peanut allergic group: documented peanut allergy verified by a doctor and meeting specific allergy test criteria
- For Part 2: willing to complete food challenge tests and meet specific peanut allergy criteria
You will not qualify if you...
- History of severe anaphylactic event requiring mechanical ventilation or IV vasopressors
- Significant abnormal ECG or prolonged QTcF interval
- Lung function (FEV1) below 80% predicted
- Recent hospitalization or emergency visits for asthma or frequent steroid use
- Poorly controlled atopic dermatitis or eosinophilic gastrointestinal disease
- Recent use of corticosteroids, tricyclic antidepressants, immunomodulatory or immunosuppressive drugs
- Inability to stop antihistamines before skin testing
- Use of beta-blockers
- Significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or kidney disease
- Pregnant or breastfeeding women
- Behavioral or psychiatric conditions interfering with study participation
- Known allergy to study product ingredients
- Participation in another interventional trial recently
- Living with another participant in this or any peanut immunotherapy study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 to 14 weeks for Part 1, then up to 52 weeks for Part 2
Participants receive daily buccal administrations of ENP-501 or placebo. Part 1 lasts 6 to 14 weeks, followed by Part 2 lasting up to 52 weeks after achieving the target dose.
Regular visits throughout treatment duration
Trial Site Locations
Total: 1 location
1
Research Site 001
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
B
Balraj Sangha
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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