Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL003 · 1 trial · 2 indications
Incidence of adverse events during the treatment and follow up periods through out the study.
| Arm | Type | Description |
|---|---|---|
| AL003 by intravenous (IV) infusion | ACTIVE_COMPARATOR | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in single cohort |
| Placebo by intravenous (IV) infusion | PLACEBO_COMPARATOR | Matching saline solution will be administered for placebo subjects |
| Name | Type | Description |
|---|---|---|
| AL003 | BIOLOGICAL | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort |
| Saline Solution | OTHER | Saline 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 |
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...
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AL003 is an investigational monoclonal antibody being developed by Alector, Inc. for Alzheimer disease. It is a Phase 1 candidate that has been studied in a first-in-human trial evaluating safety and tolerability. AL003 has not been approved for any indication and remains in clinical development.
AL003 is being developed as a potential treatment for Alzheimer disease. Its clinical evaluation so far has focused on safety and tolerability rather than confirmed efficacy. Alector, Inc. is the developer, and the program is at the Phase 1 stage of clinical development.
AL003 is being developed by Alector, Inc., which trades on the Nasdaq under the ticker ALEC. Alector is a clinical-stage biotechnology company, and AL003 is one of its neurology-focused antibody programs. The company sponsored the first-in-human study of AL003.
AL003 is in Phase 1 clinical development. Its only recorded trial, NCT03822208, was a Phase 1 first-in-human study that has been completed. AL003 is investigational and has not been approved by the FDA for Alzheimer disease or any other indication.
AL003 has been evaluated in one clinical trial, NCT03822208, titled First in Human Study for Safety and Tolerability of AL003. The Phase 1 trial enrolled 54 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States and Australia. It is now completed.
The Phase 1 trial NCT03822208 enrolled 54 participants, including healthy volunteers and people with Alzheimer disease, and was open to adults 18 years and older of any sex. It was a randomized, double-blind, placebo-controlled study conducted in the United States and Australia.