Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435507
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-05-20
Brief Title:
Phase I Clinical Trial to Evaluate the Safety Tolerability and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
Sponsor:
Innovative Molecules GmbH
Organization:
Innovative Molecules GmbH
Study Overview
Official Title:
Phase I Clinical Trial to Evaluate the Safety Tolerability and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-10
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 first-in-human phase I open-label monocenter single dose-escalation study with 4 cohorts The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up
Twenty-four participants are planned to be enrolled in the trial Each cohort may be expanded by up to 6 additional volunteers resulting in a maximum of 48 participants possibly enrolled in the trial
Ninety-six volunteers may need to be screened to include 48 volunteers
Twenty-four participants are planned to be enrolled in the trial Each cohort may be expanded by up to 6 additional volunteers resulting in a maximum of 48 participants possibly enrolled in the trial
Ninety-six volunteers may need to be screened to include 48 volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None