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AL003

Phase 1

Healthy | Monoclonal antibody | Neurology |Alector, Inc.|Last Updated: Sep 17, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

AL003 · 1 trial · 2 indications

Phase 1 1
NCT03822208First in Human Study for Safety and Tolerability of AL003.Healthy
COMPLETED54 Analytics
PHASE1COMPLETED
First in Human Study for Safety and Tolerability of AL003.
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Study Endpoints

Primary Endpoints

Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE)
141 days

Incidence of adverse events during the treatment and follow up periods through out the study.

Secondary Endpoints

Pharmacokinetics (PK) of AL003
85 days
Maximum concentration (Cmax) for AL003
85 days
Area under the curve concentration (AUC) for AL003
85 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AL003 by intravenous (IV) infusionACTIVE_COMPARATORSingle-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in single cohort
Placebo by intravenous (IV) infusionPLACEBO_COMPARATORMatching saline solution will be administered for placebo subjects

Interventions

NameTypeDescription
AL003BIOLOGICALSingle-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort
Saline SolutionOTHERSaline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Total body weight between 50 and 120 kg, inclusive 2. 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 signi...

Countries:United StatesAustralia
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Frequently asked questions about AL003

What is AL003?

AL003 is an investigational monoclonal antibody being developed by Alector, Inc. for potential use in neurology. It is currently in Phase 1 clinical development. The drug has been studied in a first-in-human trial that included healthy volunteers and participants with Alzheimer's disease.

What is AL003 used for?

AL003 is being studied for use in Alzheimer's disease. A Phase 1 clinical trial evaluated the drug in healthy volunteers and in participants with Alzheimer's disease to assess its safety and tolerability. The drug is still in early clinical development and is not yet approved for any use.

How does AL003 work?

AL003 is a monoclonal antibody, a type of biologic drug designed to bind to a specific target in the body. However, the specific molecular target of AL003 has not been disclosed in available information. The drug is being investigated for its potential role in treating neurological conditions.

Who makes AL003?

AL003 is being developed by Alector, Inc., a biopharmaceutical company. Alector is publicly traded under the ticker symbol ALEC. The company is focused on developing therapies for neurodegenerative diseases.

What phase is AL003 in?

AL003 is in Phase 1 clinical development. A Phase 1 first-in-human study (NCT03822208) has been completed. This early-stage trial was designed to evaluate the safety and tolerability of the drug in healthy volunteers and in people with Alzheimer's disease.

What clinical trials is AL003 in?

AL003 has one completed Phase 1 clinical trial, registered as NCT03822208, titled "First in Human Study for Safety and Tolerability of AL003." The trial enrolled 54 participants, including healthy volunteers and individuals with Alzheimer's disease, and was conducted in the United States and Australia.