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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change from Baseline in Total Nasal Symptom Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind pharmacy controlled randomization
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: ALDP001 Nasal Spray (Drug)
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
干预措施: ALDP001 Nasal Spray (Drug)
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
干预措施: ALDP001 Nasal Spray (Drug)
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
干预措施: Placebo Nasal spray (Drug)
结局指标
主要结局
Change from Baseline in Total Nasal Symptom Score
时间窗: 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) 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (noticeable and bothersome, but tolerable) 3. \- 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.
次要结局
- Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9(Day 9)