NCT03636204

A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics

Detailed description

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation carriers.

Conditions

• Healthy
• Frontotemporal Dementia

Interventions

Type	Name	Description
BIOLOGICAL	AL001	Active dose of AL001
OTHER	Placebo	Saline solution administered as a single infusion as palcebo.

Timeline

• Start date: 2018-09-14
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-08-17
• Last updated: 2020-07-27

Locations

8 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study