TB006 for Autism Spectrum Disorder

This study is testing a drug called TB006 for adults with Autism Spectrum Disorder (ASD). TB006 is a special type of antibody designed to block a protein called Galectin-3 (Gal-3), which is thought to contribute to inflammation in the brain in people with ASD. The researchers believe that by blocking Gal-3, TB006 might help improve core and related symptoms of ASD. You may be able to join if you are between 18 and 35 years old, have a moderate or higher severity of ASD, and speak English. The study plans to enroll 45 participants. Success will be measured by changes in your Childhood Autism Rating Scores (CARS) at 8 and 14 weeks. The current recruitment status is unclear.

Study design
This is a multi-site, 14-week study where participants will be randomly assigned to receive either TB006 or a placebo (an inactive substance) in a 2:1 ratio. It is a double-blind study, meaning neither you nor your doctor will know if you are receiving TB006 or the placebo.
What's involved
You would have assessments at the start of the study (baseline), and again at Week 8 and Week 14. If you receive the placebo, you may have the option to receive TB006 in an open-label extension phase after the initial 14 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your Childhood Autism Rating Scores (CARS) will be measured at Week 8 and Week 14 after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06500637

TB006 for Autism Spectrum Disorder

Recruiting
PHASE2Ages 18–35InterventionalTreatment
Rossignol Medical Center
~45 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:TB006

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Childhood Autism Rating Scores (CARS)
Measured over Baseline, Week 8 and Week 14
Autism Spectrum Disorder

NCT06500637

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rossignol Medical Center

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Rossignol Medical Center

    Aliso Viejo, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Richard E Frye, M.D., Ph.D · STUDY_DIRECTOR · Rossignol Medical Center
  • Daniel A Rossignol, MD · PRINCIPAL_INVESTIGATOR · Rossignol Medical Center

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  • Childhood Autism Rating Scores (CARS)Baseline, Week 8 and Week 14

    The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.