Polyrizon Launches Human Study Measuring NASARIX™ Nasal Residence Time
PLRZ•Polyrizon executed an agreement with a leading European university medical center and a specialized CRO to conduct a human performance study measuring NASARIX™ residence time under EU MDR and GCP standards. The study’s serial endoscopic evaluations will quantify barrier duration and support planned FDA regulatory submissions.
1. Agreement and Collaboration
Polyrizon has signed agreements with a top European university medical center and a specialized clinical research organization to initiate a human performance and characterization study for NASARIX™ (PL-14) Allergy Blocker. This collaboration secures expert clinical oversight and regulatory-compliant operations under EU MDR and GCP frameworks.
2. Study Design and Objectives
The single-site investigation will enroll healthy participants and employ serial endoscopic visualization techniques to track the residence time, distribution, and persistence of the intranasal hydrogel formulation. Data collected will estimate the duration of the protective barrier function in vivo, a critical parameter for real-world efficacy.
3. Regulatory Strategy and Next Steps
Results from this verification and validation program will feed into Polyrizon’s regulatory dossier, informing planned submissions to the U.S. FDA and European health authorities. The company anticipates that high-quality retention data will de-risk further development and support future clinical trial design and market authorization.
