Clinical Research Directory

Inclusion Criteria: * Aged ≥12 years and ≤60 years, male or female; * History of wheat or gluten allergy; * Positive skin prick test (SPT) to the allergen (wheat or gluten), and/or positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat/gluten extract or ω 5 gliadin) at screening or within three months prior to screening; * Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening; * No plan to conceive and agree to use effective contraceptive measures throughout the trial period; * The participant and/or parent/legal representative understands and voluntarily signs the informed consent form. Exclusion Criteria: * Allergic to LP-003 Injection or its excipients; * Uncontrolled asthma or severe asthma at screening; * Any severe disease; * History of severe allergic reactions to wheat or gluten; * Not enough washing-out period for previous therapy before the food exercise challenge at screening.