drugset
drugset / Trial / NCT06013150

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

NCT06013150 ↗

Phase 1 Completed 24 enrolled De Motu Cordis Novotech (Australia) Pty Limited · collab
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2023-10-24
Primary completion
2023-12-15
Completion
2024-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Epinephrine Other / unclassified 1 mg Inhaled
Subject Epinephrine Other / unclassified 1.3 mg Inhaled
Subject Epinephrine Other / unclassified 1.5 mg Inhaled

Indications

anaphylaxis