A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
A Two-part Adaptive Double-blind Randomized Placebo-controlled Study to Assess the Appropriate Dose and the Appropriate Dosing Frequency of ALDP 001 in Adults With Seasonal Allergic Rhinitis (SAR) Assessed Using an Allergen Challenge Chamber/EEC
Alixer Nexgen Therapeutics Limited
164 participants
Oct 17, 2025
INTERVENTIONAL
Conditions
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 formulation.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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.
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Interventions
Experimental Arm
Controlled arm
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07219849