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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06435507
Study type Interventional
Source Innovative Molecules GmbH
Contact
Status Recruiting
Phase Phase 1
Start date April 25, 2023
Completion date August 30, 2024

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