Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL101 · 1 trial · 1 indication
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
| Arm | Type | Description |
|---|---|---|
| AL101 IV | EXPERIMENTAL | * Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort) |
| Saline Solution | PLACEBO_COMPARATOR | Saline solution will be administered with the following: * Single IV infusion for four single ascending doses (SAD IV cohorts) in a ratio of 8 active and 3 placebo subjects * Multiple IV infusions for the MD IV cohort in a ratio of 8 active and 2 placebo subjects |
| AL101 SC | EXPERIMENTAL | * Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC |
| Name | Type | Description |
|---|---|---|
| AL101 | BIOLOGICAL | Active dose of AL101 |
| Placebo | OTHER | Saline solution administered as a single and multiple infusion as placebo. |
Inclusion Criteria: * 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 o...
AL101 is an investigational monoclonal antibody developed by Alector, Inc. It has been studied in a Phase 1 first-in-human clinical trial that assessed its safety and tolerability. The study enrolled 88 healthy adult volunteers in the United States. AL101 has not been approved by the FDA and remains in clinical development.
AL101 is being developed by Alector, Inc., a biotechnology company that trades under the ticker symbol ALEC. Alector sponsored the Phase 1 first-in-human study of AL101, which was conducted in the United States. The program is part of the company's pipeline of investigational monoclonal antibody therapies.
AL101 is in Phase 1 clinical development. Its only recorded trial, NCT04111666, was a Phase 1 first-in-human study that has been completed. That trial enrolled 88 participants and evaluated safety and tolerability in healthy volunteers. AL101 is investigational and has not received FDA approval.
AL101 has been evaluated in one clinical trial, NCT04111666, titled a Phase 1 first-in-human study to assess safety and tolerability of AL101. The trial was completed, enrolled 88 healthy adult volunteers, and was conducted in the United States. It was randomized, double-blind, and placebo-controlled.
Yes. The Phase 1 first-in-human trial of AL101, NCT04111666, was randomized, double-blind, and placebo-controlled. It enrolled 88 healthy volunteers aged 18 years and older in the United States and has been completed. The study was designed to assess the safety and tolerability of AL101.