Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

Study Overview
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Brief Summary
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Determine the effect of ARS-1 on a patient reported pruritus/hive score

Official Title
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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

Conditions
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Urticaria

Intervention / Treatment
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* Drug: ARS-1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 9. Provide written informed consent prior to participating in the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARS-1 1mg<br>1 mg per 100 µL dose of ARS-1 | Drug: ARS-1<br>* A single treatment of ARS-1.<br>|
| Active Comparator: ARS-1 2mg<br>2 mg per 100 µL dose of ARS-1 | Drug: ARS-1<br>* A single treatment of ARS-1.<br>|
| Placebo Comparator: Placebo<br>Placebo (100 µL) | Drug: Placebo<br>* A single treatment of placebo nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score | Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score. | Assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing. |