Clinical TrialJun 15, 2026, 04:07 PM
Polyrizon Advances NASARIX™ Development with Key Human Study
AI Summary
Polyrizon Ltd. announced an agreement with a leading European university medical center and a clinical research organization (CRO) to conduct a human study for its NASARIX™ (PL-14) Allergy Blocker. This study will evaluate the nasal residence time of the formulation, a key performance parameter to assess its protective barrier function. The data generated from this human performance and characterization study is intended to support the company's regulatory strategy, including planned submissions to the U.S. Food and Drug Administration (FDA).
Key Highlights
- Polyrizon signed agreements with a European medical center and a CRO for a human study.
- The study will evaluate the nasal residence time of NASARIX™ (PL-14) Allergy Blocker.
- The assessment aims to support the estimation of the product's protective barrier function duration.
- This is a human performance and characterization study, not an interventional clinical trial.
- Data from the study will support Polyrizon's FDA regulatory strategy and planned submissions.
- The study will adhere to Regulation (EU) 2017/745 (MDR) and Good Clinical Practice (GCP) standards.
- The single-site study involves healthy participants and uses endoscopic visualization techniques.
Price Impact
More from PLRZ