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

NCT03636204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-07-27

No results posted yet for this study

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

Conditions

  • Healthy
  • Frontotemporal Dementia

Interventions

BIOLOGICAL

AL001

Active dose of AL001

OTHER

Placebo

Saline solution administered as a single infusion as palcebo.

Sponsors & Collaborators

  • Alector Inc.

    lead INDUSTRY

Principal Investigators

  • George Stoica · Bioclinica Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636204 on ClinicalTrials.gov