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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Canada
Cliantha Research
RECRUITING
Mississauga
Contact Information
Primary
Akhilesh Sharma
akhilesh.sharma@alkem.com
+912239829999
Backup
Yogesh Rane
yogesh.rane@alkem.com
+919820587254
Time Frame
Start Date:2025-10-17
Estimated Completion Date:2026-04
Participants
Target number of participants:164
Treatments
Experimental: ALDP001 0.125% w/v
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Experimental: ALDP001 (0.25% w/v)
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Experimental: ALDP001 (0.5% w/v) Nasal Spray
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Placebo_comparator: Placebo Nasal Spray
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days