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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects
Sponsor: Aquestive Therapeutics
Summary
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.
Official title: A Phase 1, Multi-Site, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DESF in Pediatric Subjects ≥30 kg With a Personal History of Allergic Reactions at High Risk for Serious Reactions (PARKS: Pediatric Anaphylm Response, Kinetics, and Safety)
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-12-26
Completion Date
2025-05-21
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
DESF
DESF administered in the sublingual space
Locations (8)
AllerVie Clinical Research
Birmingham, Alabama, United States
UCLA Pediatric Allergy & Immunology
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
IAA Clinical Research
Wheaton, Maryland, United States
Rochester Regional Health AIR
Rochester, New York, United States
Texas Children's Hospital - Feigin Center
Houston, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Halton Pediatric Allergy
Burlington, Ontario, Canada