FMXIN002 in Patients at Risk of Anaphylaxis

NCT07045701 | Enrolling By Invitation Phase 2

• 1 other identifier: NP-009-Epinephrine
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Skin system anaphylaxis symptoms

  Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021

  0-90 minutes after drug administration

• Mucosal system anaphylaxis symptoms

  Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021

  0-90 minutes after drug administration

• Gastrointestinal system anaphylaxis symptoms

  Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.

  0-90 minutes after drug administration

• Respiratory system anaphylaxis symptoms

  Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.

  0-90 minutes after drug administration

• Total anaphylaxis severity score

  Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.

  0-90 minutes after drug administration

• Vital signs: Blood pressure

  Systolic and diastolic blood pressure by a blood pressure cuff

  0-90 minutes after drug administration

• Vital signs: pulse rate

  heart rate by pulse rate measurement

  0-90 minutes after drug administration

• Vital signs: oxygen saturation

  % oxygen saturation measurement using oxygen monitor

  0-90 minutes after drug administration

Secondary Outcomes (2)

• Need for a second epinephrine dose

  0-90 minutes after drug administration

• Adverse events

  0-90 minutes after drug administration

Study Arms (2)

FMXIN002 4mg + saline IM

EXPERIMENTAL

Epinephrine powder nasal spray together with a placebo IM injection

Combination Product: Epinephrine 4mg nasal powder spray

Adrenaline 0.5mg IM + placebo nasal spray

ACTIVE COMPARATOR

Epinephrine IM injection together with a placebo nasal spray

Combination Product: Adrenalin 0.5mg Injectable Product

Interventions

Epinephrine 4mg nasal powder spray COMBINATION_PRODUCT

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

Also known as: FMXIN002

FMXIN002 4mg + saline IM

Adrenalin 0.5mg Injectable Product COMBINATION_PRODUCT

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

Adrenaline 0.5mg IM + placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years, any gender
• Documented or suspected food allergy (based on IgE level or clinical history)
• Development of Grade II or III reaction during OFC

You may not qualify if:

• Age \<18 or \>40
• Poorly controlled asthma (FEV1 \< 80% or frequent symptoms)
• Active eosinophilic esophagitis
• Pregnancy or risk of pregnancy
• Mild (Grade I) or very severe (Grade IV) reactions during OFC
• Decline to participate

Sponsors & Collaborators

• Nasus Pharma: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

MeSH Terms

Interventions

Epinephrine; Injections

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Arnon Elizur, Prof.

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 1, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 12, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)