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Nasal spray may offer fast hives relief without needles

NCT ID NCT05496465

Symptom relief Sponsor: ARS Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single dose of a nasal spray called ARS-1 (intranasal epinephrine) in 21 adults who get frequent hives and itching. The goal was to see if the spray works faster and better than a placebo at reducing itch and hive scores during flare-ups. Participants were monitored for safety and symptom improvement over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urticaria

Contacts and locations

Locations

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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