Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2025-06-12
2026-07-12
Brief Summary
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Study Design
• Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FMXIN002 4mg + saline IM
Epinephrine powder nasal spray together with a placebo IM injection
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
Adrenaline 0.5mg IM + placebo nasal spray
Epinephrine IM injection together with a placebo nasal spray
Adrenalin 0.5mg Injectable Product
Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.
Interventions
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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
Adrenalin 0.5mg Injectable Product
Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented or suspected food allergy (based on IgE level or clinical history)
* Development of Grade II or III reaction during OFC
Exclusion Criteria
* 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
18 Years
40 Years
ALL
No
Sponsors
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Nasus Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Arnon Elizur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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Shamir Medical Center
Be’er Ya‘aqov, , Israel
Countries
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Other Identifiers
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NP-009-Epinephrine
Identifier Type: -
Identifier Source: org_study_id
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