ALDP001 Nasal Spray for Seasonal Allergic Rhinitis
A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
Recruiting
Phase 2Interventional Study
Seasonal Allergic Rhinitis (SAR)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
Alixer Nexgen Therapeutics Limited · Industry
Who this trial is looking for
This trial is looking for adults with seasonal allergic rhinitis who want to try a nasal spray treatment. Participants will help determine the best dose and how often to use the spray.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with allergic rhinitis for over a year.
I have seasonal rhinitis symptoms for several months each year.
I have a positive skin test for ragweed pollen in the last 12 months.
I am healthy according to a medical evaluation.
You may not be able to join if
I have nasal abnormalities like polyps or a perforated septum.
I have a history of frequent nosebleeds.
I cannot use medications for rhinitis relief.
I have a history of liver disease.
I have a QTcF interval over 450 ms if I'm male or over 470 ms if I'm female.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 …
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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