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

Overview

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.

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).

Conditions

Interventions

Eligibility

Locations (8)

Outcomes