Anaphylaxis FoodPhase 2/3NCT07045701
FMXIN002 in Patients at Risk of Anaphylaxis
A Phase 2/3 study testing Epinephrine 4mg nasal powder spray and Adrenalin 0.5mg Injectable Product in people with Anaphylaxis Food, run by Nasus Pharma at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anaphylaxis Food
- What is being tested?
- Epinephrine 4mg nasal powder spray and Adrenalin 0.5mg Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Jun 2025to 12 Jul 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis
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.
Read the detailed description
Study Procedures
- Informed Consent: Participants will sign consent forms.
- Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.
- Assessment: At the first signs of allergic symptoms, a physician will assess the subject.
- 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.
- Randomization: 1:1 between the 2 study arms.
- Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.
- Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).
- 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.
- 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).
- 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
- Discharge: Participants with symptom resolution by 90 minutes will be discharged.
- Conditions
- Anaphylaxis Food
- Being tested
- Epinephrine 4mg nasal powder spray, Adrenalin 0.5mg Injectable Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 4mg nasal powder sprayCombination product
Also called FMXIN002
Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection
Adrenalin 0.5mg Injectable ProductCombination product
Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.
| Study group | Role | What they receive |
|---|---|---|
| FMXIN002 4mg + saline IM | Experimental | Epinephrine powder nasal spray together with a placebo IM injection Receives: 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 Receives: Combination Product: Adrenalin 0.5mg Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-90 minutes after drug administration
Vital signs: Blood pressure
Systolic and diastolic blood pressure by a blood pressure cuff
Measured: 0-90 minutes after drug administration
Vital signs: pulse rate
heart rate by pulse rate measurement
Measured: 0-90 minutes after drug administration
Vital signs: oxygen saturation
% oxygen saturation measurement using oxygen monitor
Measured: 0-90 minutes after drug administration
Secondary outcomes (2)
Need for a second epinephrine dose
Number of patients needed a second dose, by Adrenalin IM injection
Measured: 0-90 minutes after drug administration
Adverse events
Any treatment-related adverse events
Measured: 0-90 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start12 Jun 2025
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaphylaxis FoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nasus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnon Elizur, Prof., Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045701
- Sponsor's protocol ID
- NP-009-Epinephrine
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis
- ClinicalTrials.gov ID
- NCT07045701
- Acronym / sponsor ID
- NP-009-Epinephrine
- Conditions
- Anaphylaxis Food
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nasus PharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Informed Consent: Participants will sign consent forms.
- Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.
- Assessment: At the first signs of allergic symptoms, a physician will assess the subject.
- 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.
- Randomization: 1:1 between the 2 study arms.
- Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.
- Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).
- 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.
- 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).
- 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
- Discharge: Participants with symptom resolution by 90 minutes will be discharged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMXIN002 4mg + saline IM | Experimental | Combination Product: Epinephrine 4mg nasal powder sprayEpinephrine powder nasal spray together with a placebo IM injection |
| Adrenaline 0.5mg IM + placebo nasal spray | Active comparator | Combination Product: Adrenalin 0.5mg Injectable ProductEpinephrine IM injection together with a placebo nasal spray |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine 4mg nasal powder sprayAlso: FMXIN002Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection | Combination product | FMXIN002 4mg + saline IM |
| Adrenalin 0.5mg Injectable ProductEpinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray. | Combination product | Adrenaline 0.5mg IM + placebo nasal spray |
Primary outcome
Skin system anaphylaxis symptoms
Time frame: 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
Time frame: 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
Time frame: 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.
Respiratory system anaphylaxis symptoms
Time frame: 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.
Total anaphylaxis severity score
Time frame: 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
Time frame: 0-90 minutes after drug administration
Systolic and diastolic blood pressure by a blood pressure cuff
Vital signs: pulse rate
Time frame: 0-90 minutes after drug administration
heart rate by pulse rate measurement
Vital signs: oxygen saturation
Time frame: 0-90 minutes after drug administration
% oxygen saturation measurement using oxygen monitor
2 secondary outcomes
Need for a second epinephrine dose
Time frame: 0-90 minutes after drug administration
Adverse events
Time frame: 0-90 minutes after drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnon Elizur, Prof. principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epinephrine 4mg nasal powder spray and Adrenalin 0.5mg Injectable Product in people with Anaphylaxis Food, run by Nasus Pharma at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin system anaphylaxis symptoms (time frame: 0-90 minutes after drug administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.