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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy, Frontotemporal Dementia

In brief

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

Key facts

Study ID

NCT03636204

Run by

Alector Inc.

People needed

64

Starts

2018-09-14

Expected to finish

2019-12-31

Last updated by the study team

2020-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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 may not qualify 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• UCSF — San Francisco, California, United States
• Study site — Orlando, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Lawson Health Research Institute, St. Joseph's — London, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Canada
• University College London — London, United Kingdom

Full record on ClinicalTrials.gov

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