A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults with ALS
The purpose of this trial is to determine the safety and tolerability of multiple doses of AT-1501 (study drug) in participants with ALS. Additionally, the trial will look at the effects of AT-1501 on the ALSFRS-R, SVC, biomarkers, and the body’s immune response.
Four ascending doses of AT-1501 (1mg/kg, 2mg/kg, 4mg/kg, or 8mg/kg) will be administered as a 1-hour IV infusion and 2-hour post-dose observation period. Each dose will make up a separate, sequential dosing cohort (Cohorts 1, 2, 3, or 4).
Participants in each cohort will receive a total of 6 biweekly infusions over an 11-week period.
Principal Investigator: Shafeeq Ladha, MD