A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects

An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions. All treated participants will receive a single dose of DESF on Study Day 1. On Study Day 2, participants will return to the study site for an Oral Mucositis Assessment Scale (OMAS) assessment.

NCT Number	NCT07703982
Lead Sponsor	Aquestive Therapeutics
Conditions	Allergic Reaction
Enrollment	32 participants
Start Date	2024-12-26
Primary Completion	2025-03-14 (estimated)
Study Completion	2025-05-21 (estimated)
Updated on ClinicalTrials.gov	2026-07-15