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NCT Number: NCT07219849

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis (SAR) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliantha Research

Mississauga, Ontario, Canada

Location status: Recruiting

Location contact

Patricia Couroux, MD

CONTACT

[email protected]

(905) 282-1808

Patricia Couroux, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALDP001 Nasal Spray

Drug

Experimental Arm

Placebo nasal spray

Drug

Controlled arm

Primary outcomes

  1. Change from Baseline in Total Nasal Symptom Score

    Time frame: 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)

    • - Mild (minimal awareness, easily tolerated)
    • - Moderate (noticeable and bothersome, but tolerable)
    • - 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 outcomes

  1. Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9

    Time frame: 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 outcomes

  1. Number of participants with Adverse events (AEs), with abnormal Clinical Laboratory Parameters, abnormal ECG readings

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Akhilesh Sharma

CONTACT

[email protected]

+912239829999

Yogesh Rane

CONTACT

[email protected]

+919820587254

Sponsors and collaborators

Lead sponsor

Alixer Nexgen Therapeutics Limited

Industry

Registry information

Official study 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

Acronym: ALDP001

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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