Status:
RECRUITING
A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
Lead Sponsor:
Alixer Nexgen Therapeutics Limited
Conditions:
Seasonal Allergic Rhinitis (SAR)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 formula...
Detailed Description
The study will be conducted in two Parts. In Part A, participants will receive a once-daily (OD) dose of the nasal spray for eight days. An interim analysis will then be performed to identify the opti...
Eligibility Criteria
Inclusion
- Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities
- Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control) in the previous 12 months
- Healthy as determined by a responsible and experienced Investigator, based on a medical evaluation including medical history, physical examination, vital signs, ECG, and lab tests.
Exclusion
- Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis and other nasal malformations.
- History of frequent nosebleeds.
- Participants with rhinitis medicamentosa.
- Current or chronic history of hepatic disease.
- A QTcF (Fridericia-corrected QT interval) \>450 ms in males or \>470 ms in females.
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT07219849
Start Date
October 17 2025
End Date
April 1 2026
Last Update
October 22 2025
Active Locations (1)
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1
Cliantha Research
Mississauga, Ontario, Canada