drugset / Trial / NCT05921929
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2024-05-02
- Primary completion
- 2024-05-02
- Completion
- 2024-05-02
Outcome
Outcome not reported
Stopped: “a new trial should be designed”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluoroethylnormemantine | Unknown | 20 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 40 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 80 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 120 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 160 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 200 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 240 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 260 mg/kg | Oral |
| Subject | Fluoroethylnormemantine | Unknown | 320 mg/kg | Oral |