Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis

Summary

Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled allergic rhinitis to be effective against a wide range of common respiratory allergens. It is an immuneenhancer. The primary purpose of the study is to demonstrate safety in a first into man study on 24 human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that demonstrate a response to a nasal allergen challenge using grass pollen. The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period nasal symptom scores, eosinophil counts and cytokine measurements will be performed.

Timeline

Start

2006-10

Primary completion

—

Completion

2007-03

Drugs

Indications