NCT03635047

A Phase I Study for Safety and Tolerability of AL002.

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a multi-centre, 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 AL002.

Detailed description

The study will be conducted in 2 phases: In the single ascending dose (SAD) phase up to approximately 56 healthy adult participants will be sequentially enrolled into up to approximately 9 cohorts In the multiple-dose (MD) phase, approximately 32 patients with mild to moderate Alzheimer's disease will be enrolled in three cohorts.

Conditions

• Healthy
• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	AL002	Single-doses of AL002 in up to 9 dose-escalating cohorts
OTHER	Saline Solution	Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients

Timeline

• Start date: 2018-11-12
• Primary completion: 2020-08-03
• Completion: 2020-11-25
• First posted: 2018-08-17
• Last updated: 2020-12-09

Locations

6 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study