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120 Participants NeededMy employer runs this trial

PL-14 Allergy Blocker for Hay Fever

Recruiting at 4 trial locations
HB
TT
Overseen ByTidhar Turgeman, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Polyrizon Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18–75 who have had seasonal allergies (like hay fever) for over two years, with current symptoms and a positive allergy test. Participants must not be pregnant or breastfeeding, must use effective birth control if needed, and be able to attend all study visits.

Inclusion Criteria

Positive skin prick test with wheal ≥3 mm larger than diluent control with erythema or positive in vitro specific IgE test against relevant allergen at Baseline or within 12 months before enrollment
Signed IRB/EC-approved informed consent prior to any study procedures
Willing and able to attend all trial visits
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Exclusion Criteria

Positive rapid-result COVID-19 antigen test
Planned travel outside designated pollen area for ≥24 hours during 7-day Run-in Period or ≥2 consecutive days or total ≥3 days between randomization and follow-up phone call
Concurrent participation in another clinical study or within 30 days prior to Screening
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What Are the Treatments Tested in This Trial?

Interventions

  • PL-14 Allergy Blocker

Trial Overview

The study compares PL-14 Allergy Blocker nasal gel—a drug-free barrier that blocks allergens—to a standard saline nasal spray in people with seasonal allergies. Participants are randomly assigned to one of the treatments for up to 30 days.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PL-14 Allergy BlockerExperimental Treatment1 Intervention
Group II: Ayr® Saline Nasal MistActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Polyrizon Ltd.

Lead Sponsor

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