Actively Recruiting
TB006 for Autism Spectrum Disorder
Led by Rossignol Medical Center · Updated on 2026-04-14
45
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Rossignol Medical Center
Lead Sponsor
A
Autism Discovery and Treatment Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TB006 for Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Autism Spectrum Disorder confirmed by ADOS or ADI-R
- Age between 18 and 35 years at baseline
- English is one of the languages in which the individual is raised
- Autism severity of moderate or higher (score 64 on 7-item clinical global impression-severity scale)
- Able to keep all complementary, dietary, traditional, and behavioral treatments unchanged during the study
- Treatments unchanged for at least two months before study entry
- Use of two forms of birth control if of childbearing potential unless not sexually active
- Has a caretaker who can attend all procedures and complete caregiver questionnaires
You will not qualify if you...
- Carries two copies of the Variant-type allele of LGALS3 rs4644
- History of infusion reactions to immunoglobulin products
- Significant self-abusive or violent behavior, or suicidal ideation, plan, or behavior
- Extremely ill with CGI-Severity Standard Score of 7
- Severe prematurity (born before 34 weeks gestation)
- Current uncontrolled gastroesophageal disorders
- Current or past liver or kidney disease as determined by medical history and labs
- Presence of genetic syndromes
- Congenital brain malformations
- Active epilepsy defined as history of two or more unprovoked seizures; seizure-free off medication for over two years does not qualify as active
- Any medical condition deemed unsafe or compromising data integrity by the principal investigator
- Significant adverse reactions to previous blood draws
- Failure to thrive or below 5th percentile for BMI or weight at screening
- Concurrent use of drugs that significantly interact with the study drug
- Allergy or sensitivity to ingredients in the study drug or placebo
- NIH Toolbox or BOSCC evaluation within 3 months before study entry
- Planned NIH Toolbox or BOSCC evaluation during the study
- Pregnancy
- Current DSM-5 diagnosis requiring other pharmacotherapy such as major depression, bipolar disorder, or psychotic disorders
- Refusal to comply with birth control if sexually active
- Abnormal vital signs (high or low blood pressure, heart rate, temperature, or oxygen saturation)
- Prolonged QTc interval or concerning cardiac abnormalities as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Rossignol Medical Center
Phoenix, Arizona, United States, 85050
Actively Recruiting
2
Rossignol Medical Center
Aliso Viejo, California, United States, 92656
Actively Recruiting
Research Team
A
Alina Espinoza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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