drugset / Trial / NCT06921590
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
Phase 1
Active not recruiting
6 enrolled
Alzamend Neuro, Inc.
Massachusetts General Hospital · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws
Timeline
- Start
- 2025-05-09
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Latozinemab | Monoclonal antibody | 1050 mg | Oral |
| Subject | Lithium Carbonate | Unknown | 150 mg | — |
Indications
No indication recorded.