Recruiting
Phase 2

ALDP001 Nasal Spray

Sponsor:

Alixer Nexgen Therapeutics Limited

Code:

NCT07219849

Conditions

Seasonal Allergic Rhinitis (SAR)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ALDP001 Nasal Spray

Placebo Nasal spray

Study Details

Brief 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.

Conditions

Seasonal Allergic Rhinitis (SAR)

Study ID

NCT07219849

Start date

Oct 17, 2025

Status verified date

Oct, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

ALDP001 Nasal Spray

Experimental Arm

Placebo Nasal spray

Controlled arm

Primary outcome measure

  • Change from Baseline in Total Nasal Symptom Score [ Time Frame: Day 9 ]

Central Contacts and Locations

Central contacts

Akhilesh Sharma

+912239829999akhilesh.sharma@alkem.com

Yogesh Rane

+919820587254yogesh.rane@alkem.com

Locations

Cliantha Research

Recruiting

Mississauga, Ontario, Canada

Contacts

Patricia Couroux, MD

(905) 282-1808pcouroux@cliantha.com

Principal Investigator:

Patricia Couroux, MD

More Information

Sponsor

Alixer Nexgen Therapeutics Limited

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • ALDP001 Nasal Spray

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alixer Nexgen Therapeutics Limited on 2025-10-22.