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First in Human Study for Safety and Tolerability of AL003.

Healthy Clinical Trial

Official title:
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL003 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease.

Clinical Trial Summary

This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL003.

Clinical Trial Description

The study will be conducted in 2 phases: In the single ascending dose (SAD) phase, up to approximately 42 healthy adult participants will be sequentially enrolled into up to approximately 7 cohorts. In the multiple-dose (MD) phase, approximately 12 patients with mild to moderate Alzheimer's disease will be enrolled in one cohort. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03822208
Study type Interventional
Source Alector Inc.
Contact
Status Completed
Phase Phase 1
Start date March 29, 2019
Completion date May 6, 2021
View Details
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