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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
N-Fold, LLC
Study ID
NCT07117669
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
14 Years - 50 Years
Healthy Volunteers
Accepted

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
  • 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

Study Details

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)

Key Dates

Start date
Dec 16, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ENP-501
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research Site 001AuroraColorado80045-

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