Find the best dose and schedule of ALDP001 nasal spray for seasonal allergies.
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
This study will test whether ALDP001 nasal spray, given once or twice daily, helps adults with seasonal allergic rhinitis and which dose works best.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alixer Nexgen Therapeutics Limited Industry-sponsored |
| Locations | 1 site (Mississauga, Ontario) |
| Trial ID | NCT07219849 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 2 trial uses a two-part design to identify the optimal dose and dosing frequency of ALDP001 nasal spray in adults with seasonal allergic rhinitis. In Part A participants receive once-daily dosing for eight days across multiple dose levels, followed by an interim analysis to select the lead dose. In Part B participants receive the selected formulation twice daily to compare dosing frequency against placebo. Safety monitoring includes physical exams, ECG, lab tests, and adverse event reporting, and eligibility requires a positive ragweed skin-prick test.
Who should consider this trial
Good fit: Adults with seasonal allergic rhinitis who have a positive ragweed skin-prick test within the past 12 months and are judged healthy by the study investigator.
Not a fit: Patients with nasal structural abnormalities, frequent nosebleeds, rhinitis medicamentosa, chronic hepatic disease, or prolonged QTc are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ALDP001 could offer an effective nasal spray regimen with an optimized dose and schedule to reduce seasonal allergy symptoms.
How similar studies have performed: While nasal sprays are a proven class for allergic rhinitis, ALDP001 is a novel formulation and its optimal dose and frequency have not been previously established in published trials.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Mississauga, Ontario
- Cliantha Research — Mississauga, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Patricia Couroux, MD — Cliantha Research
- Study coordinator: Akhilesh Sharma
- Email: akhilesh.sharma@alkem.com
- Phone: +912239829999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.