NCT07219849

A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Alixer Nexgen Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Seasonal Allergic Rhinitis (SAR)

Interventions

Type	Name	Description
DRUG	ALDP001 Nasal Spray	Experimental Arm
DRUG	Placebo Nasal spray	Controlled arm

Timeline

• Start date: 2025-10-17
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-10-22
• Last updated: 2025-10-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study