N-Fold, LLC
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)
Inclusion Criteria: 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 * Signed and dated assent from particip…
* 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
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