Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome

Completed · Phase 2

Conditions studied: Allergic Reaction

In brief

A 2-part open-label study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome (OAS). In both parts, subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts. In Part 1, there are three treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1), intramuscular (IM) injection without allergen challenge (Treatment Period 2), and DESF without allergen challenge (Treatment Period 3). In Part 2, there are two treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1) and intramuscular (IM) injection without allergen challenge (Treatment Period 2).

Key facts

Study ID

NCT06527937

Run by

Aquestive Therapeutics

People needed

36

Starts

2024-07-17

Expected to finish

2024-10-13

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Frontage Clinical Services, Inc. — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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