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

Completed · Phase 1

Conditions studied: Allergic Reaction

In brief

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.

Key facts

Study ID

NCT07703982

Run by

Aquestive Therapeutics

People needed

32

Starts

2024-12-26

Expected to finish

2025-05-21

Last updated by the study team

2026-07-15

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female children ages 7 through 17 years of age at the start of the Screening Period.
• Participants with a known history of allergic reactions with an active prescription for epinephrine, and who (in the judgement of the investigator) are at high risk for serious allergic reactions (e.g., anaphylaxis).
• Participant has a body weight ≥30 kg (66 lbs).
• Participant is within the 5th and 95th percentiles, inclusive, for weight by age (according to CDC growth charts).

You may not qualify if…

• Any current or past medical conditions such as significant systemic diseases that, in the investigator's opinion, might significantly affect pharmacodynamic responses to DESF.
• Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
• Known intolerance or hypersensitivity to any component of DESF.
• Participant has a disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of DESF.
• Positive urine drug screen, saliva alcohol test, or urine cotinine test at Screening or prior to administration of DESF on Study Day 1.
• Participant has participated in any clinical investigation within the 30 days prior to the planned administration of DESF on Study Day 1.

Where it is running

• 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

Full record on ClinicalTrials.gov

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