Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2025-12-17 @ 2:20 AM
Study NCT ID:
NCT06435507
Status:
None
Last Update Posted:
2024-10-24 00:00:00
First Post:
2024-05-20 00:00:00
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:
None
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