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

Status: Completed
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of South Florida
Tampa
Massachusetts
Massachusetts General Hospital
Boston
Maryland
Institute for Asthma and Allergy
Chevy Chase
Ohio
Bernstein Clinical Research Center, LLC
Cincinnati
Time Frame
Start Date: 2022-07-28
Completion Date: 2024-02-02
Participants
Target number of participants: 18
Treatments
Active_comparator: 1 mg/100 µL dose of ARS-1
Active_comparator: 2 mg/100 µL dose of ARS-1
Active_comparator: albuterol MDI (180 mcg)
Placebo_comparator: placebo
Related Therapeutic Areas
Sponsors
Leads: ARS Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov