By InvitationPhase 2/3

FMXIN002 in Patients at Risk of Anaphylaxis

Israel30 participantsStarted 2025-06-12

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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