NCT05152901

Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults

A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: De Motu Cordis · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.

Detailed description

DMC-IH1 (Investigational Product) is a capsule containing epinephrine bitartrate dry powder blend contained within a single-use, proprietary inhalation device. The planned dosages for inhalation are 0.3 mg on Visit 2, 1.3 mg (dose will not exceed 6 mg) on Visit 3, and 4 mg (dose will not exceed 6 mg) on Visit 4. The study will comprise 3 periods: Screening, Treatment, and Follow-up. Total duration of the study is approximately 66 days including -28 days from screening to visit to follow up

Conditions

• Anaphylactic Reaction

Interventions

Type	Name	Description
DRUG	EpiPen ®.	A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.
DRUG	Epinephrine (0.3mg) inhaled	Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2
DRUG	Epinephrine (1.3mg)	A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.
DRUG	Epinephrine (4mg)	A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2021-12-10
• Last updated: 2023-07-24

Locations

1 site across 1 country: Australia