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

Phase 2

Completed

• Conditions: Urticaria
• Interventions: Drug: ARS-1; Drug: Placebo

• Registration Number: NCT05496465
• Lead Sponsor: ARS Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study Start: 2022-07-28
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARS-1 1mg	ARS-1	1 mg per 100 µL dose of ARS-1
ARS-1 2mg	ARS-1	2 mg per 100 µL dose of ARS-1
Placebo	Placebo	Placebo (100 µL)

Primary Outcome Measures

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

Trial Locations

Locations (2)

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States