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

NCT ID: NCT05496465

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2024-02-29

Brief Summary

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

Conditions

Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARS-1 1mg

1 mg per 100 µL dose of ARS-1

Group Type: ACTIVE_COMPARATOR

ARS-1

Intervention Type: DRUG

A single treatment of ARS-1.

ARS-1 2mg

2 mg per 100 µL dose of ARS-1

Group Type: ACTIVE_COMPARATOR

ARS-1

Intervention Type: DRUG

A single treatment of ARS-1.

Placebo

Placebo (100 µL)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A single treatment of placebo nasal spray

Interventions

ARS-1

A single treatment of ARS-1.

Intervention Type: DRUG

Placebo

A single treatment of placebo nasal spray

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARS Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarina Tanimoto, MD, PhD

Role: STUDY_DIRECTOR

ARS Pharmaceuticals, Inc.

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

RELIEF-CSU1

Identifier Type: -

Identifier Source: org_study_id