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

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.
• 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.