Recruiting

Neffy & IM Adrenalin

Sponsor:

ARS Pharmaceuticals, Inc.

Code:

NCT06834165

Conditions

Allergic Reactions

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Interventions

Neffy

Adrenaline

Study Details

Brief summary:

The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.

Conditions

Allergic Reactions

Study ID

NCT06834165

Start date

May 20, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
  • Has body weight 15 kg or greater at the time of allergy challenge.
  • Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
  • Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.

Exclusion Criteria:

\- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Neffy

active comparator: IM adrenaline

Interventions

Neffy

Epinephrine nasal spray

Adrenaline

Epinephrine injection

Primary outcome measure

  • AEs after epinephrine treatment within 2 hours [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Osnat Ehrman, MSc.

952.334.5797osnate@pacificlinkconsulting.com

Locations

Orso Health, Inc.

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Ali Doroudchi, MD

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

University Of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Weill Cornell Medicine/NewYork Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Miriam Samstein, M.D, Ph.D.

347-834-3746mb.eichenbaum@gmail.com

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Investigator, MD

513-517-1179Yasmin.hassoun@cchmc.org

Principal Investigator:

Yasmin Hassoun, MD

More Information

Sponsor

ARS Pharmaceuticals, Inc.

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ARS Pharmaceuticals, Inc. on 2026-04-21.