Seasonal Allergic Rhinitis (SAR)
Conditions
Keywords
ALDP001 Nasal Spray
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 formulation.
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 optimal dose for the next part. In Part B, participants will be administered a twice-daily (BD) dose of the selected formulation from Part A to evaluate the appropriate dosing frequency for the regimen.
Interventions
DRUGALDP001 Nasal Spray
Experimental Arm
DRUGPlacebo Nasal spray
Controlled arm
Sponsors
Alixer Nexgen Therapeutics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind pharmacy controlled randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Nasal Symptom Score | Day 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse events (AEs), with abnormal Clinical Laboratory Parameters, abnormal ECG readings | From enrollment to End of Study i.e. 10 days | 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. |
Countries
Canada
Contacts
Primary ContactAkhilesh Sharma
Backup ContactYogesh Rane
Outcome results
None listed