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

ARS Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Asthma

Treatments: Drug: ARS-1; Drug: Placebo; Drug: Albuterol MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT05363670

EPI A01

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 4 patient groups, including a placebo group

1 mg/100 µL dose of ARS-1

Active Comparator group

Treatment:

Drug: ARS-1

2 mg/100 µL dose of ARS-1

Active Comparator group

Treatment:

Drug: ARS-1

albuterol MDI (180 mcg)

Active Comparator group

Treatment:

Drug: Albuterol MDI

placebo

Placebo Comparator group

Treatment:

Drug: Placebo