A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
NCT ID: NCT03636204
Last Updated: 2020-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2018-09-14
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AL001
Up to six single ascending doses of AL001
AL001
Active dose of AL001
Saline Solution
Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects
Placebo
Saline solution administered as a single infusion as palcebo.
Interventions
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AL001
Active dose of AL001
Placebo
Saline solution administered as a single infusion as palcebo.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Positive drug or alcohol at screening and prior to first dose
* History of alcohol abuse or substance abuse
18 Years
80 Years
ALL
Yes
Sponsors
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Alector Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George Stoica
Role: PRINCIPAL_INVESTIGATOR
Bioclinica Research
Locations
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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
Countries
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References
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Kurnellas M, Mitra A, Schwabe T, Paul R, Arrant AE, Roberson ED, Ward M, Yeh F, Long H, Rosenthal A. Latozinemab, a novel progranulin-elevating therapy for frontotemporal dementia. J Transl Med. 2023 Jun 15;21(1):387. doi: 10.1186/s12967-023-04251-y.
Other Identifiers
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AL001-1
Identifier Type: -
Identifier Source: org_study_id
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