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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-17

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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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

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Seasonal Allergic Rhinitis (SAR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind pharmacy controlled randomization

Study Groups

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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

Group Type EXPERIMENTAL

ALDP001 Nasal Spray

Intervention Type DRUG

Experimental Arm

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

Group Type EXPERIMENTAL

ALDP001 Nasal Spray

Intervention Type DRUG

Experimental Arm

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

Group Type EXPERIMENTAL

ALDP001 Nasal Spray

Intervention Type DRUG

Experimental Arm

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

Group Type PLACEBO_COMPARATOR

Placebo Nasal spray

Intervention Type DRUG

Controlled arm

Interventions

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ALDP001 Nasal Spray

Experimental Arm

Intervention Type DRUG

Placebo Nasal spray

Controlled arm

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes