Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921929
Status:
WITHDRAWN
Last Update Posted:
2024-05-03
First Post:
2023-06-06
Brief Title:
First-In-Human FIH Single Ascending Dose SAD Study of FluoroEthylNorMemantine FENM
Sponsor:
ReST Therapeutics
Organization:
ReST Therapeutics
Study Overview
Official Title:
Safety and Pharmacokinetics of a Novel NMDA Receptor Antagonist Against Brain Related Diseases in Healthy Adult Volunteers First-in-human Phase I Single Dose-escalating Open Label Study
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
a new trial should be designed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this First-In-Human FIH trial is to learn about safety and PharmacoKinetics PK in healthy adult volunteers The main questions it aims to answer are
What is the safety of single ascending doses of the FluoroEthylNorMemantine FENM
What is the PK profile of single ascending doses of the FENM in human
What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor BDNF plasmatic levels of single ascending doses of the FENM Participants will receive one single oral dose of FENM
What is the safety of single ascending doses of the FluoroEthylNorMemantine FENM
What is the PK profile of single ascending doses of the FENM in human
What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor BDNF plasmatic levels of single ascending doses of the FENM Participants will receive one single oral dose of FENM
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?:
None
Is an FDA AA801 Violation?:
None