Summary

for people ages 18-65 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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 asymptomatic FTD-GRN mutation carriers.

Keywords

Healthy Frontotemporal Dementia Dementia Aphasia, Primary Progressive Pick Disease of the Brain AL001 Saline Solution

Eligibility

You can join if…

Open to people ages 18-65

  • BMI 18.0-35.0 kg/m2
  • 45-120 kg, inclusive
  • At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
  • Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit. A
  • In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
  • Willingness and able to comply with the study protocol, in the investigator's judgement.

You CAN'T join if...

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • Positive drug or alcohol at screening and prior to first dose
  • History of alcohol abuse or substance abuse

Locations

  • UCSF not yet accepting patients
    San Francisco California 94158 United States
  • Mayo Clinic not yet accepting patients
    Rochester Minnesota 55905 United States
  • Sunnybrook Health Sciences Centre
    Toronto Canada
  • Study site not yet accepting patients
    Orlando Florida 32806 United States
  • University of Pennsylvania not yet accepting patients
    Philadelphia Pennsylvania 19104 United States
  • University College London
    London United Kingdom
  • Erasmus Medical Center not yet accepting patients
    Rotterdam Netherlands

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Alector Inc.
ID
NCT03636204
Phase
Phase 1
Study Type
Interventional
Last Updated
September 10, 2018