drugset / Trial / NCT07816432
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LP-003 | Unknown | — | Subcutaneous |