Needle-free allergy rescue: nasal spray could replace EpiPen
NCT ID NCT07228325
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new epinephrine nasal powder (FMXIN002) against the standard EpiPen injection in 50 healthy adults with allergies. Researchers will measure how quickly and effectively the nasal spray delivers epinephrine into the body and its effects on vital signs. The goal is to see if a needle-free option can work as well as the injection for treating severe allergic reactions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Non-smoking, male and female participants, from 18 to 55 years of age. 2. Documented positive skin allergy test at screening. 3. History of hay fever, seasonal allergies, or allergic rhinitis during the last year. 4. BMI ≥18 and \< =30 kg/m2. 5. Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception. * Non-childbearing potential: * Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or * Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and a FSH value consistent with being postmenopausal). 6. Able to tolerate venipuncture. 7. Be informed of the nature of the study and give written consent prior to any study procedure. 8. Willing and able to remain in the clinic for the entire duration of the confinement period. 9. Have good intravenous access on both arms and hands. - Exclusion Criteria: * History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results. * Have clinically significant findings at screening. * Females who: * Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to the first drug administration; * Have discontinued or changed the use of oral or patch hormonal contraceptives within one (1) month prior to the first drug administration; * Are pregnant (serum β-hCG consistent with pregnancy); or * Are breast-feeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pharma Medica Research Inc
Mississauga, Canada
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Other studies related to the condition(s) this trial covers.
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