Recruiting

TB006 for Core Symptoms in Adults With Autism Spectrum Disorder

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Study Aim

This phase 2 study aims to evaluate the effectiveness and safety of TB006 in reducing core autism symptoms in adults, as measured by clinician-rated autism severity scores.

What is being tested

TB006

Drug
Who is being recruted

Autism Spectrum Disorder+1

+ Mental Disorders

+ Child Development Disorders, Pervasive

From 18 to 35 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorRossignol Medical Center
Study ContactAlina Espinoza
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 3, 2024

Actual date on which the first participant was enrolled.

This study is focused on finding a new treatment for adults with Autism Spectrum Disorder (ASD) by examining a medicine called TB006. TB006 is designed to target Galectin-3, a protein that is believed to play a role in causing inflammation in the brain, which may contribute to the symptoms of ASD. The study aims to see if TB006 can help reduce these core symptoms and improve behavior in adults with ASD. By addressing this underlying inflammation, the study hopes to offer a new way to manage ASD symptoms and enhance the quality of life for those affected. Participants in this study will receive the treatment TB006, which is a type of medicine known as a monoclonal antibody, or a placebo. The study is set up to compare the effects of TB006 with a placebo to ensure any improvements are due to the treatment itself. Participants will be observed and evaluated to see if there is any improvement in their ASD symptoms and to ensure that the treatment is safe and does not cause significant side effects. The results will help determine whether TB006 is an effective treatment option for managing ASD symptoms.

Official TitleA 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
NCT06500637
Principal SponsorRossignol Medical Center
Study ContactAlina Espinoza
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

8 inclusion criteria required to participate
Autism Spectrum Disorder as defined below by the ADOS or ADI-R.
Between 18 and 35 years of age at baseline.
English included in the languages in which the individual is being raised.
Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale.
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22 exclusion criteria prevent from participating
LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele.
History of infusion reactions to immunoglobulin product.
Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior.
Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Identical IV solution without TB006 product

Group II

Experimental
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). Galectins are a ubiquitous group of proteins found in a variety of cells, tissues, and extravascular spaces, and are involved in numerous metabolic processes and functions. The galectins preferentially bind to β-galactoside derivatives and can cross-link surface glycoproteins by binding galactose residues. The Gal-3 protein plays an important role in different pathogenic conditions, including neurodegenerative and neuroinflammatory disorders. Serum levels of Gal-3 have been found to be elevated in ASD.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Rossignol Medical Center

Phoenix, United StatesOpen Rossignol Medical Center in Google Maps
Recruiting

Rossignol Medical Center

Aliso Viejo, United States
Recruiting
2 Study Centers