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

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 participant under 18 in accordance with local IRB regulations
• •Willing and able to avoid peanut and peanut contaminants for the duration of the trial
• •Part 1 Cohort 1 only (NPA Participants)
• •No known clinical history of peanut allergy with regular exposure to peanuts in daily life, i.e ingests peanuts without symptoms
• •Negative Skin Prick Test (SPT) (wheal diameter of \<3 mm) to peanut
• •Part 1 Cohort 2 only (PA Participants)
• •A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
• •At least two of the three following requirements:
• •1. Positive Skin Prick Test (SPT) (wheal diameter of ≥ 8 mm) to peanut
• •2. An elevated serum peanut specific IgE level ≥ 7 kUA/L (ImmunoCAP®)
• •3. An Ara-h2 IgE level of ≥ 2 kUA/L (ImmunoCAP®)
• •Part 2:
• •14 to 50 years of age (inclusive)
• •A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
• •At least two of the three following requirements at screening:
• •1. Positive SPT (wheal diameter of ≥ 3 mm) to peanut
• •2. Serum peanut-specific IgE level ≥ 0.7 kUA/L (ImmunoCAP®)
• •3. An Ara-h2 IgE level of ≥ 0.5 kUA/L (ImmunoCAP®) within 1 year of enrollment
• •Participant must be willing and able to complete a DBPCFC at screening and EOT (24-hours after last dose) and experience dose-limiting symptoms at or before the 300 mg challenge dose of peanut protein during a Double Blind, Placebo Controlled Food Challenge (DBPCFC) conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines
• •Otherwise medically healthy and able to participate in the study
• •Able to perform spirometry testing in accordance with the 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 participant under 18 in accordance with local IRB regulations
• •Willing and able to avoid peanut and peanut contaminants for the duration of the trial