Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.

Anaphylactic Reaction Clinical Trial

Official title: A Phase 1, 2-Part Study in Healthy Male and Female Participants; Part 1 - A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose-Escalation Study of Inhaled DMC-IH1; Part 2 - An Open-Label, 3-Arm Study Assessing the Carryover Effects of Inhaled (DMC-IH1) and Intramuscular (EpiPen®) Epinephrine

Status Not yet recruiting

Clinical Trial Summary

This is a phase 1, randomised, double blind placebo controlled 2-part study to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled DMC-IH1 (epinephrine) and relative bioavailability and carryover effects of Inhaled (DMC-IH1) and Intramuscular(IM) (EpiPen®) Epinephrine in healthy male and female participants.

Clinical Trial Description

DMC-IH1 (Investigational product) inhaler is a proprietary single-use capsule based dry powder inhaler designed for oral pulmonary drug delivery in emergency scenarios.

This study is in two parts- Part 1 will enrol 24 participants into 3 cohorts receiving a single ascending dose; Part 2 will enrol 39 participants into 3 arms to receive either DMC-IH1 through the inhaler device or epinephrine IM.

Each participant will receive 3 doses of epinephrine either inhaled (DMC-IH1) or IM at differing intervals to assess carryover effect.

Both Parts 1 and 2 of the study will comprise 3 periods: Screening, Treatment Period and Follow-up . ;

Related Conditions & MeSH terms

• Anaphylactic Reaction
• Anaphylaxis

• NCT number: NCT06013150
• Study type: Interventional
• Source: De Motu Cordis
• Contact: John Fredatovich
• Phone: +61 07 3520 0350
• Email: john.fredatovich@demotucordis.co
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 23, 2023
• Completion date: February 12, 2024