Find the best dose and schedule of ALDP001 nasal spray for seasonal allergies.
Official title: 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
Run by Alixer Nexgen Therapeutics Limited · NCT07219849 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Alixer Nexgen Therapeutics Limited Industry-sponsored |
| Locations | 1 site (Mississauga, Ontario) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | October 22, 2025 |
| Trial ID | NCT07219849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adolescent seasonal allergic rhinitis: add-on therapy with stapokibart vs placebo
This phase 3 trial tests whether adding stapokibart to standard care helps adolescents aged 12–17 with seasonal allergic rhinitis.
-
PL-14 Allergy Blocker vs saline spray for seasonal nasal allergies
This study tests whether PL-14 Allergy Blocker, a drug-free nasal gel, reduces nasal allergy symptoms in adults with seasonal allergic rhinitis compared with saline spray.
-
Rupatifen Fumarate Capsules for Seasonal Allergic Rhinitis
This Phase 3 trial tests Rupatifen Fumarate Capsules in adults with seasonal allergic rhinitis to see if they reduce symptoms compared with Rupatadine Fumarate and placebo.
-
TQH2722 injection plus regular allergy treatment for seasonal pollen allergy
This trial will test whether adding TQH2722 injections to usual care helps adults (18–75) with seasonal allergic rhinitis who had poor symptom control during pollen season.
-
Creating a risk assessment tool for thunderstorm asthma (CARISTA)
This project will test whether lung tests, allergy blood markers and daily symptom tracking can predict which adults with hay fever in South‑Eastern Australia will have seasonal or thunderstorm-related asthma attacks over two spring seasons.
-
Treatment of seasonal allergic rhinitis with MG-K10 monoclonal antibody injection
This study is testing if an injection of a new medicine called MG-K10 can help people with seasonal allergies feel better compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.