drugset / Trial / NCT05363293
Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.
Timeline
- Start
- 2022-05-04
- Primary completion
- 2023-04-14
- Completion
- 2023-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Latozinemab | Monoclonal antibody | 1890 mg | — |
| Subject | Latozinemab | Monoclonal antibody | 3150 mg | — |
| Subject | Latozinemab | Monoclonal antibody | 4410 mg | — |
| Subject | Latozinemab | Monoclonal antibody | 5040 mg | — |
| Subject | Latozinemab | Monoclonal antibody | 6300 mg | — |