NASARIX Clears All ISO 10993 Tests, Paving Way for First Human Trial
PLRZ•Polyrizon’s NASARIX biocompatibility program passed all ISO 10993-series biological safety tests, including cytotoxicity, sensitization, irritation and acute systemic toxicity. Risk assessments under ISO 10993-17 demonstrated substantial safety margins, supporting progression to first-in-human clinical trials of the drug-free mucoadhesive nasal spray.
1. Successful Biocompatibility Testing
Polyrizon’s NASARIX product cleared all required ISO 10993-series tests, including cytotoxicity, sensitization, irritation, pyrogenicity and acute systemic toxicity, meeting predetermined acceptance criteria for biological safety.
2. Toxicological Risk Assessment Findings
A toxicological risk evaluation under ISO 10993-17 confirmed substantial safety margins across NASARIX’s formulation components and materials, supporting the product’s safety profile under intended use.
3. Advancement Toward Human Trials
These biocompatibility results satisfy major nonclinical requirements and support progression to first-in-human clinical trials of the drug-free mucoadhesive nasal spray targeting seasonal allergic rhinitis.
4. NASARIX Technology Overview
NASARIX is a drug-free intranasal hydrogel designed to form a mucoadhesive barrier against airborne allergens using Polyrizon’s proprietary Capture and Contain hydrogel platform.
