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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

Enrollment Contact: 
Diana Thiessen 
(602) 406-6606

Open and enrolling subjects.
Phoenix, Arizona
Primary Sponsor
Anelixis Therapeutics, Inc.