NCT00443495

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

First Into Man Administration of Chitin Microparticles: a Randomised,Double Blind,Placebo Controlled Parallel Group Upward Titration Evaluation of 3 Dose Levels Given Intr-Nasally Over 24 Hours,Followed by a Placebo Controlled,Randomised Parallel Group Evaluation of Safety and Biological Activity Over 7 Days in Subjects Suffering From Allergic Rhinitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: CMP Therapeutics Ltd · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chitin microparticles are a special preparation of chitin. This a long chain polysaccaride derived from shells of the North Atlantic shrimp. CMP acts a an immunenhancer which improve immune function by stimulating macrophages and other cells such as T-helper lymphocytes, (Th cells). In allergies there is an imbalance between Th1 and Th2 cells. Imuneenhancers shift the balance in favour of Th1 cells. The immunomodulatory properties of CMP have been demonstrated in animal models against a wide range of respiratory allergens. There have been no indications of toxic side effects in animal models.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Chitin microparticles by nasal route

Timeline

• Start date: 2006-10-01
• Completion: 2007-03-01
• First posted: 2007-03-06
• Last updated: 2007-03-06