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COMPLETED
NCT07703982
PHASE1

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

Sponsor: Aquestive Therapeutics

View on ClinicalTrials.gov

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

Interventions

DRUG

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