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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05496465
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : August 11, 2022
Information provided by (Responsible Party):
ARS Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Urticaria Drug: ARS-1 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 28, 2022
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Itching

Arm Intervention/treatment
Active Comparator: ARS-1 1mg
1 mg per 100 µL dose of ARS-1
Drug: ARS-1
A single treatment of ARS-1.

Active Comparator: ARS-1 2mg
2 mg per 100 µL dose of ARS-1
Drug: ARS-1
A single treatment of ARS-1.

Placebo Comparator: Placebo
Placebo (100 µL)
Drug: Placebo
A single treatment of placebo nasal spray

Primary Outcome Measures :
  1. Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05496465

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Contact: Robert Hasson 16195406253 rhasson@pacificlinkconsulting.com

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United States, Ohio
Bernstein Clinical Research Center, LLC Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Karen C Berendts    531-354-1746    kbarendts@bernsteincrc.com   
Principal Investigator: David Bernstein, MD         
Sponsors and Collaborators
ARS Pharmaceuticals, Inc.
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Study Director: Sarina Tanimoto, MD, PhD ARS Pharmaceuticals, Inc.
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Responsible Party: ARS Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05496465    
Other Study ID Numbers: EPI U01
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases