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 being developed by Alector, Inc. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to assess its safety and tolerability.
AL101 is being studied for use in healthy volunteers. The ongoing clinical development focuses on evaluating the safety and tolerability of the drug in this population, rather than for a specific disease indication.
AL101 is being developed by Alector, Inc., a biopharmaceutical company. Alector's stock is traded under the ticker symbol ALEC.
AL101 is in Phase 1 clinical development. A Phase 1 first-in-human study has been completed, which assessed the safety and tolerability of the drug in healthy volunteers.
AL101 has one completed clinical trial, identified as NCT04111666. This was a Phase 1 first-in-human study conducted in the United States, enrolling 88 healthy volunteers aged 18 years and older.
AL101 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed safety and tolerability in healthy volunteers, but the drug has not yet received regulatory approval.