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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
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.
Details
| Lead sponsor | CMP Therapeutics Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2006-10 |
| Completion | 2007-03 |
Conditions
- Seasonal Allergic Rhinitis
Interventions
- Chitin microparticles by nasal route