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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

TB006 for Autism Spectrum Disorder

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

TB006 for Autism Spectrum Disorder (NCT06500637) is a Phase 2 interventional studying Autism Spectrum Disorder, sponsored by Rossignol Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Autism Spectrum Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 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. Who Should NOT Join This Trial: 1. LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele. 2. History of infusion reactions to immunoglobulin product. 3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior. 4. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill). 5. Severe prematurity (\<34 weeks gestation) as determined by medical history. 6. Current uncontrolled gastroesophageal disorders. 7. Current or history of liver or kidney disease as determined by medical history and safety labs (See Laboratory Values Monitoring Plan for specific laboratory values). 8. Genetic syndromes. 9. Congenital brain malformations. 10. Active Epilepsy Diagnosis (Epilepsy Diagnosis is defined as History of two or more unprovoked seizures; Patient with a history of epilepsy who have been off medication without seizures for more than two years do not qualify as active epilepsy). 11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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: 1. LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele. 2. History of infusion reactions to immunoglobulin product. 3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior. 4. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill). 5. Severe prematurity (\<34 weeks gestation) as determined by medical history. 6. Current uncontrolled gastroesophageal disorders. 7. Current or history of liver or kidney disease as determined by medical history and safety labs (See Laboratory Values Monitoring Plan for specific laboratory values). 8. Genetic syndromes. 9. Congenital brain malformations. 10. Active Epilepsy Diagnosis (Epilepsy Diagnosis is defined as History of two or more unprovoked seizures; Patient with a history of epilepsy who have been off medication without seizures for more than two years do not qualify as active epilepsy). 11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data. 12. Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previous blood draw. 13. Failure to thrive or \< 5%ile for Body Mass Index or weight at the time of screening. 14. Concurrent treatment with drug that would significantly interact with the investigational product. 15. Allergy or Sensitivity to ingredients in the investigational product or placebo. 16. Evaluation with the NIH Toolbox or BOSCC within 3 months of entering the study. 17. Planned evaluation with the NIH Toolbox or BOSCC during the study. 18. Pregnancy 19. Current DSM-5 diagnosis requiring alternative pharmacotherapy, e.g., Major Depression, Bipolar Disorder, a psychotic disorder (based on clinical assessment assisted by the Child and Adolescent Symptom Inventory). 20. Refusal to comply with the use of birth control if sexually active. 21. Abnormal vital signs (systolic blood pressure \> 180 mmHg or \< 90 mmHg; heart rate \> 120 beats per minute or \< 55 beats per minute; temperature \> 101.0o F; oxygen saturation \< 90%) 22. Prolonged QTc (defined as \> 450ms for males and \>470ms for female) or any abnormalities felt by the investigator to be of concern.

Treatments Being Tested

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).

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Rossignol Medical Center
Phoenix, Arizona, United States
Rossignol Medical Center
Aliso Viejo, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06500637), the sponsor (Rossignol Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06500637 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06500637?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06500637?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06500637. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06500637. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.