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Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome

NCT06527937 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-26

No results posted yet for this study

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

Interventions

DRUG

DESF

DESF administered in the sublingual space.

DRUG

Epinephrine Injection

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

Sponsors & Collaborators

  • Aquestive Therapeutics

    lead INDUSTRY

Principal Investigators

  • Frank Lee, MD · Frontage Clinical Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2024-10-10
Completion
2024-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06527937 on ClinicalTrials.gov