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

July 13, 2026 updated by: Aquestive Therapeutics

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1, multi-site, open-label, single treatment study conducted in male and female pediatric subjects (age 7-17 years) who have a have a personal history of allergic reactions and are at high risk for serious allergic reactions. This study is designed to evaluate the pharmacokinetics (PK) of epinephrine administered as a single dose of DESF.

Up to 24 DESF treated pediatric participants are expected to be enrolled. The study population will consist of healthy, non-smoking, pediatric male and female participants aged 7 through 17 with a known history of allergic reactions that the investigators believe continue to remain at high risk of serious allergic reactions (e.g., anaphylaxis).

All treated participants will be administered a single, 12 mg, dose of DESF on Study Day 1. No other investigational product will be administered.

The expected maximum duration of an individual's participation in this study will be, approximately, 32 days including a 30-day Screening Period, a 1-day Treatment Period (Study Day 1) and a 1-day (±1 day) Post-treatment Follow-up (Study Day 2).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Halton Pediatric Allergy
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • AllerVie Clinical Research
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Pediatric Allergy & Immunology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • IAA Clinical Research
    • New York
      • Rochester, New York, United States, 14607
        • Rochester Regional Health AIR
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital - Feigin Center
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc. / Foothill Family Clinic South

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Dose of DESF
A single dose (12 mg) of DESF administered.
Drug: DESF
DESF administered in the sublingual space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-10
Time Frame: 0 to 10 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
0 to 10 minutes
AUC0-20
Time Frame: 0 to 20 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
0 to 20 minutes
AUC0-30
Time Frame: 0 to 30 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
0 to 30 minutes
AUC0-45
Time Frame: 0 to 45 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
0 to 45 minutes
Cmax
Time Frame: 0 to 240 minutes post-dose
Baseline Corrected Maximum Epinephrine Plasma Concentration
0 to 240 minutes post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aquestive Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2024

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

May 21, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AQ109302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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