drugset / Trial / NCT07816432

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

NCT07816432 ↗

Phase 2 Not yet recruiting 12 enrolled Longbio Pharma
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-09-04
Primary completion
2027-07-16
Completion
2027-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject LP-003 Unknown — Subcutaneous

Indications