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

CompletedPhase 2

Sponsor: ARS Pharmaceuticals, Inc.

Conditions: Asthma

Interventions: ARS-1 1 mg, Albuterol MDI, Placebo, ARS-1 2mg

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (4)

Tampa, Florida, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States