TB006 for Autism Spectrum Disorder

Prior treatment

• Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previous blood draw.
• Concurrent treatment with drug that would significantly interact with the investigational product.
• Allergy or Sensitivity to ingredients in the investigational product or placebo.

Other illness

• History of infusion reactions to immunoglobulin product.
• Current uncontrolled gastroesophageal disorders.
• Genetic syndromes.
• 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).
• Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
• Failure to thrive or \< 5%ile for Body Mass Index or weight at the time of screening.
• 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).
• 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%)

Lab values

• 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).
• Prolonged QTc (defined as \> 450ms for males and \>470ms for female) or any abnormalities felt by the investigator to be of concern.

Other

• LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-type allele.
• 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).
• Severe prematurity (\<34 weeks gestation) as determined by medical history.
• Congenital brain malformations.
• Evaluation with the NIH Toolbox or BOSCC within 3 months of entering the study.
• Planned evaluation with the NIH Toolbox or BOSCC during the study.
• Pregnancy
• Refusal to comply with the use of birth control if sexually active.

• 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.
• Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
• Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry.
• In males and females of childbearing age, two forms of birth control must be used unless they are not sexually active.
• A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.