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FMXIN002 in Patients at Risk of Anaphylaxis

NCT07045701 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-01

No results posted yet for this study

Summary

Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis.

Study Design

• Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.

Conditions

  • Anaphylaxis Food

Interventions

COMBINATION_PRODUCT

Epinephrine 4mg nasal powder spray

Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection

COMBINATION_PRODUCT

Adrenalin 0.5mg Injectable Product

Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.

Sponsors & Collaborators

  • Nasus Pharma

    lead INDUSTRY

Principal Investigators

  • Arnon Elizur, Prof. · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-06-12
Completion
2026-07-12

Countries

  • Israel

Study Locations

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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 NCT07045701 on ClinicalTrials.gov