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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARS Pharmaceuticals, Inc.
• Treatments: Albuterol

Criteria

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.