Status:
COMPLETED
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome
Lead Sponsor:
Aquestive Therapeutics
Conditions:
Allergic Reaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a 2-Part, Phase 2, open-label, three-period, six-treatment, fixed sequence, stratified study conducted in healthy male and female adult subjects (age 18-55 years) who have oral allergy syndrom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06527937
Start Date
July 17 2024
End Date
October 13 2024
Last Update
September 26 2025
Active Locations (1)
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1
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07094