NCT03822208

First in Human Study for Safety and Tolerability of AL003.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	AL003	Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort
OTHER	Saline Solution	Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo

Timeline

• Start date: 2019-03-29
• Primary completion: 2021-05-06
• Completion: 2021-05-06
• First posted: 2019-01-30
• Last updated: 2021-09-17

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study