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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

RecruitingPhase 2Ages 18 Years - 65 YearsAllAlixer Nexgen Therapeutics Limited
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • ALDP001 Nasal Spray
  • Placebo Nasal spray
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Where

1 site
Cliantha Research
Mississauga, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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