Trials / Withdrawn
WithdrawnNCT05921929
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
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- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ReST Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
- PTSD
- Alzheimer Disease
- Brain Diseases
- Neuro-Degenerative Disease
- Major Depressive Disorder
- Treatment Resistant Depression
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluoroethylnormemantine (FENM) | Single ascending oral dose administration according to the following scheme: 20, 40, 80, 120-160, 200-240, 260-320mg/kg (six dose levels). The three upper dose levels to be administered (120-160, 200-240, 260-320mg/kg) will be precisely determined with the data collected at the end of the first three dose levels administered. |
Timeline
- Start date
- 2024-05-02
- Primary completion
- 2024-05-02
- Completion
- 2024-05-02
- First posted
- 2023-06-27
- Last updated
- 2024-05-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05921929. Inclusion in this directory is not an endorsement.