Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03636204
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2018-07-12
Brief Title:
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin GRN Mutation
Sponsor:
Alector Inc
Organization:
Alector Inc
Study Overview
Official Title:
A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia FTD With Granulin Mutation
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None