Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

Urticaria Clinical Trial

Official title:

A Single-Dose, Randomized, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05496465
• Other study ID #: EPI U01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: ARS Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effect of ARS-1 on a patient reported pruritus/hive score

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1. Male or female subject between the ages of 18 and 65 years.
• 2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
• 3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
• 4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
• 5. At screening, has stable vital signs.
• 6. If female, is not pregnant or breastfeeding.
• 7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.

8. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

Exclusion Criteria:

• 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
• 2. Patients receiving beta blocker due to potential interaction with the study drug.
• 3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
• 4. Clinically significant medical condition or physical exam finding.
• 5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
• 6. Mucosal inflammatory disorders.
• 7. Significant traumatic injury or major surgery within 30 days prior to study screening.
• 8. Has donated blood or had an acute loss of blood (>50 mL) during the 30 days before study drug administration.
• 9. Known hypersensitivity to any compound in the test product.
• 10. Participated in a clinical trial within 30 days prior to the first dose of study drug.

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• ARS-1
A single treatment of ARS-1.
• Placebo
A single treatment of placebo nasal spray

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ARS Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score	Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score.	Assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.