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

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.

Timeline

Start

2024-12-26

Primary completion

2025-03-14

Completion

2025-05-21

Drugs

Indications