Polyrizon Ltd.
This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR). PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining. This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days. The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.
Seasonal Allergic Rhinitis (SAR) is a common chronic condition associated with symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching triggered by exposure to airborne allergens. PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act purely as a mechanical barrier in the nasal cavity, significantly reducing contact between inhaled allergens and the nasal mucosa. PL-14 Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting the alleviation of mild allergic symptoms, including itchy, runny, or conge…
Inclusion Criteria: 1. Clinical history of seasonal AR, as reported by the subject, with symptoms for more than two years and exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen/ragweed). 2. Positive skin prick test (i.e., wheal ≥3 mm larger than the diluent control with erythema) or positive in vitro tests for specific IgE against allergen(s) relevant to the enrollment period at Baseline or within 12 months before enrollment . 3. Age ≥ 18 years and ≤ 75 years at Screening. 4. Active symptoms of seasonal AR with an rTNSS score ≥5 at randomization…
PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act as a mechanical barrier in the nasal cavity to reduce contact between inhaled allergens and the nasal mucosa.
Ayr® Saline Nasal Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.