A Multi-center Double Blind Placebo Controlled Study to Assess the Safety and Efficacy of TB006 for Improving Core Symptoms in Adults With Autism Spectrum Disorder
Rossignol Medical Center
Summary
Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.
Description
A key molecular mechanism implicated in ASD is immune dysregulation and unchecked neuroinflammation marked by increased microglial activation. Galectin-3 (Gal-3), a galactoside-binding lectin, is critical to activation of neuroinflammation resulting in the proliferation of microglia.7 Gal-3 has been shown to be elevated in individuals with ASD. To inhibit Gal-3's contribution to neuroinflammation, Truebinding has developed TB006, a neutralizing monoclonal antibody against Gal-3. Our overall hypothesis is that TB006 will significantly improve core and associated behavioral symptoms of ASD and b…
Eligibility
- Age range
- 18–35 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Autism Spectrum Disorder as defined below by the ADOS or ADI-R. 2. Between 18 and 35 years of age at baseline. 3. English included in the languages in which the individual is being raised. 4. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. 5. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period. 6. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry. 7. In males and females of childbearing…
Interventions
- DrugTB006
TB006 is a humanized immunoglobulin G4 (IgG4) (S228P) type monoclonal antibody that is highly specific and has a high affinity to human Galectin-3 (hGal-3).
Locations (2)
- Rossignol Medical CenterPhoenix, Arizona
- Rossignol Medical CenterAliso Viejo, California