Actively Recruiting
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
Led by N-Fold, LLC · Updated on 2026-04-24
68
Participants Needed
1
Research Sites
150 weeks
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
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
Official Title
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 50 years inclusive
- Medically healthy and able to participate in the study
- Able to perform spirometry testing according to ATS guidelines (2019)
- Women of child-bearing potential agree to abstain from sexual activity or use effective contraception during the study and for 30 days after last dose
- Signed informed consent (and assent if under 18) as per regulations
- Willing and able to avoid peanuts and peanut contaminants throughout the trial
- For Part 1 Cohort 1 (non-peanut allergic): no history of peanut allergy and regular peanut exposure without symptoms, negative skin prick test (wheal <3 mm) to peanut
- For Part 1 Cohort 2 (peanut allergic): documented peanut allergy with symptoms verified by a doctor and at least two of the following: positive skin prick test (wheal ≥8 mm), peanut-specific IgE ≥7 kUA/L, or Ara-h2 IgE ≥2 kUA/L
- For Part 2: documented peanut allergy with symptoms verified by a doctor, at least two of the following at screening: positive skin prick test (wheal ≥3 mm), peanut-specific IgE ≥0.7 kUA/L, or Ara-h2 IgE ≥0.5 kUA/L within 1 year
- Willing and able to complete double-blind placebo-controlled food challenges at screening and end of treatment
You will not qualify if you...
- History of severe anaphylaxis requiring mechanical ventilation or intravenous vasopressors
- Clinically significant ECG abnormalities or corrected QTcF ≥450 msec at screening
- FEV1 less than 80% predicted at screening
- Hospitalization for asthma in past year, more than 1 course of oral steroids for asthma in past 6 months, or any emergency room visit for asthma in past 6 months
- 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 stop antihistamines for at least 5 half-lives before skin testing
- Use of omalizumab, other immunomodulatory or biologic therapies within 1 year of screening
- Use of food allergen-specific or other non-traditional allergen immunotherapy within 1 year of screening
- Use of immunosuppressive drugs within 30 days of screening
- Use of oral beta-blockers
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Pregnant or breastfeeding
- Behavioral, cognitive, or psychiatric conditions affecting ability to participate
- Known allergy to inactive ingredients of investigational product
- Participation in another interventional clinical trial within 30 days or 5 half-lives of other investigational product
- Living at same address as another participant in this or any peanut immunotherapy study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site 001
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
B
Balraj Sangha
CONTACT
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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