NCT07703982

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

December 17, 2024

Last Update Submit

July 13, 2026

Conditions

Allergic Reaction

Outcome Measures

Primary Outcomes (5)

  • Cmax

    Baseline Corrected Maximum Epinephrine Plasma Concentration

    0 to 240 minutes post-dose

  • AUC0-10

    Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes

    0 to 10 minutes

  • AUC0-20

    Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes

    0 to 20 minutes

  • AUC0-30

    Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes

    0 to 30 minutes

  • AUC0-45

    Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes

    0 to 45 minutes

Study Arms (1)

Single Dose of DESF

EXPERIMENTAL

A single dose (12 mg) of DESF administered.

Drug: DESF

Interventions

DESFDRUG

DESF administered in the sublingual space

Single Dose of DESF

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

UCLA Pediatric Allergy & Immunology

Los Angeles, California, 90095, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

IAA Clinical Research

Wheaton, Maryland, 20902, United States

Location

Rochester Regional Health AIR

Rochester, New York, 14607, United States

Location

Texas Children's Hospital - Feigin Center

Houston, Texas, 77030, United States

Location

J. Lewis Research Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

July 15, 2026

Study Start

December 26, 2024

Primary Completion

March 14, 2025

Study Completion

May 21, 2025

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(7)