Study of TB006 to Improve Symptoms in Adults Aged 18 to 35 with Autism Spectrum Disorder

What this Trial Is About

Researchers are evaluating TB006, a monoclonal antibody targeting Galectin-3, in adults with Autism Spectrum Disorder ASD. This study explores whether TB006 can improve core and associated behavioral symptoms by reducing neuroinflammation linked to increased microglial activation. The trial is a Phase 2, multisite, double-blind, placebo-controlled randomized clinical trial with a 14-week treatment phase followed by a 14-week open-label extension for placebo subjects. Participants will be randomly assigned in a 21 ratio to receive either TB006 or a placebo. TB006 is given as an intravenous infusion and is designed to neutralize Galectin-3, which is elevated in individuals with ASD. Those initially receiving placebo will have the opportunity to receive TB006 during the open-label extension. The study measures changes in autism symptoms using various clinical scales over the 14 weeks. During the study, participants will attend regular visits for assessments including Childhood Autism Rating Scores CARS at baseline, week 8, and week 14. Additional evaluations include the NIH Toolbox, Clinical Global Impression Scale, Social Responsiveness Scale, and behavioral checklists. Caregivers will also provide input through questionnaires. Safety monitoring includes vital signs and laboratory tests. Overall participation spans the double-blind phase and potential open-label extension, totaling up to 28 weeks.

TB006 for Autism Spectrum Disorder