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

ConditionPeanut Allergy

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age14-50

SponsorN-Fold, LLC

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs

Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF >/= 450 msec at Screening

FEV1 value < 80% predicted at Screening

Any hospitalization in the past year for asthma, >1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma

Trial design

Treatments tested in this trial

ENP-501
Placebo

Treatment groups

68 Participants

are divided into 2 treatment groups

Sponsors and collaborators

N-Fold, LLC

Lead sponsor

CBCC Global Research

Collaborator

Source ClinicalTrials.gov