Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

NCT06834165 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

DRUG

Neffy

Epinephrine nasal spray

DRUG

Adrenaline

Epinephrine injection

Sponsors & Collaborators

  • ARS Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2027-04-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834165 on ClinicalTrials.gov