Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome

NCT06527937 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AQ109206
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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). 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).

Conditions

Allergic Reaction

Outcome Measures

Primary Outcomes (5)

• Cmax

  Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)

  0 to 240 minutes post-dose

• AUC0-10

  Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes

  0 to 10 minutes

• AUC0-20

  Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes

  0 to 20 minutes

• AUC0-30

  Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes

  0 to 30 minutes

• AUC0-45

  Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes

  0 to 45 minutes

Study Arms (2)

Single Doses of DESF and Intramuscular Manual Injection

EXPERIMENTAL

Single dose of DESF (12 mg) administered after allergen challenge (Treatment Period 1), followed by a single dose of intramuscular (IM) manual injection (0.3 mg) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a single dose of DESF (12 mg) without allergen challenge after a 14-day washout period from Treatment Period 1.

Drug: DESF; Drug: Epinephrine Injection

Repeat Doses of DESF and Intramuscular Manual Injection

EXPERIMENTAL

Repeat dose of DESF (24 mg \[12 mg x 2\]) administered after allergen challenge (Treatment Period 1), followed by a repeat dose of IM manual injection (0.6 mg \[0.3 mg x 2\]) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a repeat dose of DESF (24 mg \[12 mg x 2\]) without allergen challenge after a 14-day washout period from Treatment Period 1.

Drug: DESF; Drug: Epinephrine Injection

Interventions

DESF DRUG

DESF administered in the sublingual space.

Repeat Doses of DESF and Intramuscular Manual Injection; Single Doses of DESF and Intramuscular Manual Injection

Epinephrine Injection DRUG

Epinephrine manual injection administered intramuscularly according to the approved prescribing information.

Repeat Doses of DESF and Intramuscular Manual Injection; Single Doses of DESF and Intramuscular Manual Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Aquestive Therapeutics: lead

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Frank Lee, MD

  Frontage Clinical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: July 17, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 13, 2024
• Last Updated: September 26, 2025

Record last verified: 2024-11

Locations

US (1)