Clinical Trials

FMXIN002 in Patients at Risk of Anaphylaxis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 40 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07045701
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nasus Pharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arnon Elizur, Prof.
Principal Investigator Affiliation	Assaf-Harofeh Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	Israel
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaphylaxis Food

Additional Details

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.

Arms & Interventions

Arms

Experimental: FMXIN002 4mg + saline IM

Epinephrine powder nasal spray together with a placebo IM injection

Active Comparator: Adrenaline 0.5mg IM + placebo nasal spray

Epinephrine IM injection together with a placebo nasal spray

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.

Contact a Trial Team

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International Sites

Shamir Medical Center, Be'er Ya'aqov, Israel

Status

Address

Shamir Medical Center

Be'er Ya'aqov, ,

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