No-Needle epinephrine: could a dissolving film replace the shot?
NCT ID NCT06527937
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 study tested a new dissolvable film called DESF that delivers epinephrine under the tongue. Thirty-six healthy adults with oral allergy syndrome received DESF and standard epinephrine injections to compare how quickly the drug enters the bloodstream. The goal is to see if this needle-free option can work as a fast and easy treatment for allergic reactions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DESF (sublingual epinephrine film)
- What this could lead to
- If successful, DESF could offer a needle-free way to quickly deliver epinephrine during allergic reactions, making treatment easier and faster.
- What could go wrong
- This is an early Phase 2 study with only 36 healthy adults, not people having severe reactions. It measures drug levels, not real-world outcomes, so results may not translate to emergency use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
36 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Oct 2024
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to provide written informed consent and capable of following the protocol-required guidelines. * Healthy males and females 18 through 55 years of age. * Body weight ≥50 kg for males and ≥45 kg for females. * BMI ≥18 kg/m2 to ≤32 kg/m2. * Known history of oral allergy syndrome in response to exposure to any of the allergens (e.g., apple, cherry, mango, melon, kiwi, celery, banana and/or carrot). * Able to tolerate venipuncture. * Subject has not had exposure to antihistamines within 3 days prior to the Screening visit. Exclusion Criteria: * Any current 'clinically significant' medical condition(s) that, in the opinion of the investigator, could confound the assessment of safety or impact assessments of PK and/or PD parameters or the safety of the subjects in the trial such as significant systemic neurological, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, oncologic and/or metabolic disease. * Clinically significant laboratory results at Screening, including, but not limited to hemoglobin \<11.5 g/dL for males or \<10.5 g/dL for females. * Clinically significant 12-lead ECG findings (at any time). * Known history or presence of hypersensitivity or idiosyncratic reaction to DESF, epinephrine, or other drug substances with similar activity including intolerance or hypersensitivity to any component of DESF. * Known history or presence of any disorder of the sublingual mucosa or any disease or condition which affects the normal production of saliva (e.g., xerostomia, Ehlers-Danlos syndrome, or Sjögren's syndrome) which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. * Subject has a disorder of the sublingual mucosa that, in the opinion of the investigator, would impact or interfere with administration, retention or absorption of DESF.
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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.
Contacts and locations
Locations
-
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094, United States
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