A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

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.