Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07219849

A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure

Led by Alixer Nexgen Therapeutics Limited · Updated on 2025-10-22

164

Participants Needed

1

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.

CONDITIONS

Official Title

A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of allergic rhinitis with seasonal symptoms lasting several months per year for more than 1 year
  • Positive skin prick test to ragweed pollen with wheal diameter at least 3 mm larger than negative control within the past 12 months
  • Healthy based on medical history, physical exam, vital signs, ECG, and lab tests as determined by an investigator
Not Eligible

You will not qualify if you...

  • Nasal abnormalities such as septal perforation, nasal polyps, sinusitis, or other malformations that may affect study results
  • History of frequent nosebleeds
  • Presence of rhinitis medicamentosa
  • Current or chronic liver disease
  • QTcF interval greater than 450 ms in males or greater than 470 ms in females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cliantha Research

Mississauga, Ontario, Canada

Actively Recruiting

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Research Team

A

Akhilesh Sharma

CONTACT

Y

Yogesh Rane

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure | DecenTrialz