Phase 2A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the safety and tolerability of ANX005, which is a monoclonal antibody that is being developed to treat ALS in adult patients by blocking abnormal complement activity, which is the part of the immune system that fights against infections. Participants will receive an induction dosing of ANX005 administered via intravenous infusion on Day 1, which will be given over approximately 21 hours during an overnight inpatient hospital stay. The 2nd induction dose will be given on Day 5 or Day 6, followed by 5 maintenance doses administered approximately 2 weeks apart. After participants have undergone all study drug infusions, participants will complete monthly study visits to assess clinical and safety outcomes on a monthly basis for 3 months, then will be contacted by phone about 6 months later to assess safety. Overall, participants may be in the research study for approximately 12 months.
Principal Investigators: Shafeeq Ladha, MD