Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 12:03 PM
Study NCT ID:
NCT06013150
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.
Sponsor:
De Motu Cordis
Organization:
Study Overview
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:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Part 1 will enrol 24 participants into 3 cohorts receiving a single ascending dose.
Study will comprise 3 periods: Screening, Treatment Period and Follow-up.
Part 1 will enrol 24 participants into 3 cohorts receiving a single ascending dose.
Study will comprise 3 periods: Screening, Treatment Period and Follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: