NCT05496465已完成2 期
A Single-Dose, Randomized, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score
研究概览
简要总结
Determine the effect of ARS-1 on a patient reported pruritus/hive score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •1. Male or female subject between the ages of 18 and 65 years.
- •2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
- •3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
- •4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
- •5. At screening, has stable vital signs.
- •6. If female, is not pregnant or breastfeeding.
- •7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.
- •8. Is able to communicate clearly with the Investigator and staff.
- •Provide written informed consent prior to participating in the study.
排除标准
- •1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
- •2. Patients receiving beta blocker due to potential interaction with the study drug.
- •3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
- •4. Clinically significant medical condition or physical exam finding.
- •5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
- •6. Mucosal inflammatory disorders.
- •7. Significant traumatic injury or major surgery within 30 days prior to study screening.
- •8. Has donated blood or had an acute loss of blood (>50 mL) during the 30 days before study drug administration.
- •9. Known hypersensitivity to any compound in the test product.
- •10. Participated in a clinical trial within 30 days prior to the first dose of study drug.
研究组 & 干预措施
ARS-1 1mg
Active Comparator
1 mg per 100 µL dose of ARS-1
干预措施: ARS-1 (Drug)
ARS-1 2mg
Active Comparator
2 mg per 100 µL dose of ARS-1
干预措施: ARS-1 (Drug)
Placebo
Placebo Comparator
Placebo (100 µL)
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score
时间窗: Assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.
Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score.
次要结局
未报告次要终点
研究者
研究点 (2)
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