FMXIN002 in Patients at Risk of Anaphylaxis

Not Applicable

• Conditions: Anaphylaxis Food

• Registration Number: NCT07045701
• Lead Sponsor: Nasus Pharma

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.

Detailed Description

Study Procedures

1. Informed Consent: Participants will sign consent forms.

2. Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.

3. Assessment: At the first signs of allergic symptoms, a physician will assess the subject.

4. Treatment Criteria: If a Grade II or III anaphylactic reaction occurs, the participant will receive either:

A). Intranasal spray of epinephrine FMXIN002 4mg + placebo saline injection B). Intranasal spray of placebo + intramuscular epinephrine injection (Adrenalin 0.5mg)

One administration will always be epinephrine; the other, placebo.

5. Randomization: 1:1 between the 2 study arms.

6. Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.

7. Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).

8. Supportive Treatment: All participants will receive antihistamines (Fenistil drops + fexofenadine 180 mg or desloratadine 5 mg). Inhaled bronchodilators (e.g., Ventolin) will be provided for respiratory symptoms as needed.

9. Monitoring: Assessments at baseline, symptom onset, and at 3, 5, 10, 15, 30, and 90 minutes post-treatment. Vital signs and system-based symptom assessments will be recorded (Appendix 3).

10. Rescue Therapy: If no improvement in 3-5 minutes, a second IM epinephrine dose (0.5 mg) will be given. Further treatment will follow standard anaphylaxis protocols

11. Discharge: Participants with symptom resolution by 90 minutes will be discharged.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study Start: 2025-06-12
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-06-12
• Study Completion: 2026-07-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory system anaphylaxis symptoms	0-90 minutes after drug administration	Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Vital signs: pulse rate	0-90 minutes after drug administration	heart rate by pulse rate measurement
Skin system anaphylaxis symptoms	0-90 minutes after drug administration	Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Mucosal system anaphylaxis symptoms	0-90 minutes after drug administration	Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Gastrointestinal system anaphylaxis symptoms	0-90 minutes after drug administration	Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Total anaphylaxis severity score	0-90 minutes after drug administration	Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Vital signs: Blood pressure	0-90 minutes after drug administration	Systolic and diastolic blood pressure by a blood pressure cuff
Vital signs: oxygen saturation	0-90 minutes after drug administration	% oxygen saturation measurement using oxygen monitor

Secondary Outcome Measures

Name	Time	Method
Need for a second epinephrine dose	0-90 minutes after drug administration	Number of patients needed a second dose, by Adrenalin IM injection
Adverse events	0-90 minutes after drug administration	Any treatment-related adverse events

Trial Locations

Locations (1)

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel