drugset / Trial / NCT05363293

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

NCT05363293

Phase 1/2 Completed 65 enrolled Alzamend Neuro, Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications