TB006 for Autism Spectrum Disorder

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 globalimpression-severity scale.

5. Ability to maintain all ongoing complementary, dietary, traditional, and behavioraltreatments constant for the study period.

6. Unchanged complementary, dietary, traditional, and behavioral treatments for twomonths prior to study entry.

7. In males and females of childbearing age, two forms of birth control must be usedunless they are not sexually active.

8. A caretaker who will accompany the patient to all procedures and has adequatecontact with the participant to complete caregiver questionnaires.

Exclusion Criteria:

1. LGALS3 rs4644 single nucleotide polymorphism with two copies of the Variant-typeallele.

2. History of infusion reactions to immunoglobulin product.

3. Significant self-abusive or violent behavior or evidence of suicidal ideation, planor 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 andsafety 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 moreunprovoked seizures; Patient with a history of epilepsy who have been off medicationwithout 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 thestudy subject or compromise the integrity of the data.

12. Significant negative reaction (i.e., fainting, vomiting, etc.) because of a previousblood 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 theinvestigational 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., MajorDepression, Bipolar Disorder, a psychotic disorder (based on clinical assessmentassisted 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; oxygensaturation < 90%)

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