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

Alixer Nexgen Therapeutics Limited

Status and phase: Enrolling; Phase 2

Conditions: Seasonal Allergic Rhinitis (SAR)

Treatments: Drug: Placebo Nasal spray; Drug: ALDP001 Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219849

ALK45-ALDP001/ C2D05456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 4 patient groups, including a placebo group

ALDP001 0.125% w/v

Experimental group

Description:

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

Treatment:

Drug: ALDP001 Nasal Spray

ALDP001 (0.25% w/v)

Experimental group

Description:

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

Treatment:

Drug: ALDP001 Nasal Spray

ALDP001 (0.5% w/v) Nasal Spray

Experimental group

Description:

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

Treatment:

Drug: ALDP001 Nasal Spray

Placebo Nasal Spray

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Nasal spray