Status:
COMPLETED
First in Human Study for Safety and Tolerability of AL003.
Lead Sponsor:
Alector Inc.
Conditions:
Healthy
Alzheimer Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study ...
Detailed Description
The study will be conducted in 2 phases: In the single ascending dose (SAD) phase, up to approximately 42 healthy adult participants will be sequentially enrolled into up to approximately 7 cohorts. ...
Eligibility Criteria
Inclusion
- Total body weight between 50 and 120 kg, inclusive
- Clinical laboratory evaluations (including chemistry panel fasted \[at least 8 hours\], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator. A count of the segmented neutrophils and bands should be performed when results from the white blood cells (WBCs) are not within the reference range.
- Negative test for selected drugs of abuse at screening (dose not include alcohol) and at admission (does include alcohol breath test). A positive result may be verified by re-testing (up to one false positive result permitted) and may be followed up at the discretion of the Investigator.
- Females must be non-pregnant and non-lactating, and either surgically sterile, using double barrier method or abstinence.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital signs.
- For MD cohort
- Ages 50-85 years, inclusive.
- The participant should be capable of completing assessments alone, per local guidelines.
- Availability of a person ("study partner") who, in the Investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion, and signs the necessary consent form, per local guidelines.
- Clinical diagnosis of probable Alzheimer's disease dementia based on National Institute on Aging Alzheimer's Association criteria.
Exclusion
- Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose of study drug.
- Participation in a clinical trial within 30 days before randomization; use of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day 1, whichever is greater. Participants who have received an experimental therapy that has no half-life, like a vaccine, should have completed that therapy at least 12 weeks prior to Day 1. Participants who have received an experimental vaccine against a central nervous system (CNS) target, such as beta-amyloid or tau, are not eligible for this study.
- Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the last dose. It is advised that prospective participants receive their annual influenza vaccine as early as possible in advance of the flu season, and then wait 2 weeks prior to randomization. It is permitted to receive the annual influenza vaccine during the screening period.
- Surgery or hospitalization during the 4 weeks prior to screening.
- Planned procedure or surgery during the study.
- Systemically, clinically significantly immunocompromised patients, owing to continuing effects of immune suppressing medication.
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Past history of seizures, with the exception of childhood febrile seizures.
Key Trial Info
Start Date :
March 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03822208
Start Date
March 29 2019
End Date
May 6 2021
Last Update
September 17 2021
Active Locations (6)
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1
Brain Matters Research
Delray Beach, Florida, United States, 33445
2
Charter Research
Lady Lake, Florida, United States, 32159
3
PPD Clinical Research Unit
Orlando, Florida, United States, 32806
4
Synexus AES
The Villages, Florida, United States, 32162