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

Conditions

• Allergic Reaction

Eligibility Criteria

Sex

ALL

Age

7 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• DESF — DRUG
  DESF administered in the sublingual space

Study Details

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 Dates

First listed

Jul 15, 2026

Start date

Dec 26, 2024

Status verified

Jul 2026

Primary completion

Mar 14, 2025

Completion

May 21, 2025

Study Design

Enrollment

32 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Dose of DESF
  A single dose (12 mg) of DESF administered.

Primary Outcome Measure

Cmax [ Time Frame: 0 to 240 minutes post-dose ]

Locations (7)

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