NCT06500637 · Rossignol Medical Center
TB006 for Autism Spectrum Disorder
What this study is about
Multisite 14-week forward-looking where neither patients nor doctors know which treatment is given placebo controlled parallel-group randomly assigned clinical trial with 14-week where both patients and doctors know the treatment given extension at the end of where neither patients nor doctors know which treatment is given treatment phase for placebo subjects.
View original scientific description
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.
Interventions
DRUG
TB006
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).
Primary outcome measures
Childhood Autism Rating Scores (CARS)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 age, two forms of birth control must be used unless they are not sexually active. 8. A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.
Exclusion criteria
- LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele. 2. History of infusion reactions to immunoglobulin prod
Where
- Phoenix, Arizona
- Aliso Viejo, California
Collaborators
Autism Discovery and Treatment Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations