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.
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.
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.
Parallel
ALDP001 Nasal Spray
DrugExperimental Arm
Placebo Nasal spray
DrugControlled arm
Change from Baseline in Total Nasal Symptom Score
Total Nasal Symptom Score (TNSS) is calculated by summing scores from four nasal symptoms: itchy nose, nasal congestion, runny nose, and sneezing. Each symptom is rated on a scale from 0 to 3, where: 0 - None (no symptoms) 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (noticeable and bothersome, but tolerable) 3. \- Severe (difficult to tolerate, interferes with daily activities or sleep) The total score ranges from 0 to 12. Participants will record TNSS at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The change from baseline (CFB) at each timepoint will be calculated and compared between study arms to evaluate the treatment effect of ALDP001 Nasal Spray.
Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9
The Area Under the Curve (AUC) for the Total Nasal Symptom Score (TNSS) will be calculated based on measurements taken at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The TNSS is a composite score assessing nasal symptoms including congestion, rhinorrhea, itching, and sneezing. Each symptom is rated on a scale from 0 (no symptoms) to 3 (severe symptoms), resulting in a total score range of 0 to 12, where higher scores indicate worse nasal symptoms. The change from baseline in the AUC for TNSS after the treatment period will be analyzed and compared across study arms to assess the efficacy of the intervention. A lower AUC value indicates better symptom control, and the AUC is expected to be lowest for the optimum dose group, reflecting improved treatment efficacy. The change from baseline in AUC of the TNSS for each dose group will be analyzed to identify the optimum dose.
Number of participants with Adverse events (AEs), with abnormal Clinical Laboratory Parameters, abnormal ECG readings
The number of participants who experience adverse events (AEs), as well as those presenting with abnormal clinical laboratory parameters (including hematology, biochemistry, and urinalysis) and abnormal ECG findings (such as QT interval prolongation), will be recorded and analyzed to evaluate the safety profile of the investigational product.
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