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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
Clinical Trial
A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults with ALS
This research study is designed to assess the safety and tolerability of an investigational drug called AT-1501, which is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by your immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance or mimic (copy) the immune system's attack process, they can also tone down the immune system, which is how the investigational drug is thought to work. It is believed that the immune system plays a role in the development of ALS.
Eligibility Criteria
- Inclusion Criteria: FVC (Forced Vital Capacity) equal to or greater than 60%. No more than 24 months from diagnosis. Exclusion Criteria: Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more). History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers.
RESEARCH. INNOVATION. DISCOVERY.