Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma

A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 or Albuterol in Subjects With Persistent Asthma

ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.

Inclusion Criteria:

• 1. Is a male or female subject between the ages of 12 and 65 years, inclusive.
• 2. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
• 3. Reversible bronchoconstriction.
• 4. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
• 5. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
• 6. At screening, has stable vital signs.

Exclusion Criteria:

• 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
• 2. Patients receiving beta blocker.
• 3. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
• 4. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
• 5. Has mucosal inflammatory disorders.
• 6. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.