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TB006 for Autism

Phase 2
Recruiting
Led By Daniel A Rossignol, MD
Research Sponsored by Rossignol Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 35 years of age at baseline
Be between 18 and 65 years old
Must not have
Genetic syndromes
Severe prematurity (<34 weeks gestation) as determined by medical history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, weeks 4, 8, 12 and 14

Summary

This trial will last for 14 weeks and will be done at multiple locations. It will be double-blind, meaning neither the participants nor the researchers will know who is receiving the real treatment or the placebo

Who is the study for?
This trial is for individuals with Autism Spectrum Disorder. Participants should be able to attend multiple site visits over a 14-week period and are willing to potentially continue in an open-label extension phase.
What is being tested?
The study tests TB006's effectiveness compared to a placebo in treating Autism Spectrum Disorders. It's designed as a double-blind, meaning neither the participants nor the researchers know who gets what treatment until after the results are collected.
What are the potential side effects?
Since specific side effects of TB006 aren't provided, they may range from none to mild or severe, depending on individual reactions. Common drug-related side effects could include nausea, headaches, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosed genetic syndrome.
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I was born severely premature, before 34 weeks of pregnancy.
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I have uncontrolled stomach or esophagus problems.
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I have a specific genetic variation related to LGALS3.
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My condition is extremely severe.
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I am not taking any medications that would interfere with the study drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, weeks 4, 8, 12 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, weeks 4, 8, 12 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Childhood Autism Rating Scores (CARS)
Secondary study objectives
Aberrant Behavior Checklist (ABC)
Clinical Global Impression Scale (CGI)
Major Parental Concerns
+4 more
Other study objectives
Galectin-3 levels

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498
14%
Thyroid function test abnormal
14%
Pyrexia
14%
Blood urea increased
14%
Gastroenteritis
14%
Sinus tachycardia
14%
Nausea
14%
Asthenia
14%
Fatigue
14%
COVID-19
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Placebo
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Part 1: Placebo
Part 1: TB006 420 mg qw
Part 2: TB006 1000 mg qw
Part 1: TB006 1000 mg qw

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TB006Experimental Treatment1 Intervention
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). Galectins are a ubiquitous group of proteins found in a variety of cells, tissues, and extravascular spaces, and are involved in numerous metabolic processes and functions. The galectins preferentially bind to β-galactoside derivatives and can cross-link surface glycoproteins by binding galactose residues. The Gal-3 protein plays an important role in different pathogenic conditions, including neurodegenerative and neuroinflammatory disorders. Serum levels of Gal-3 have been found to be elevated in ASD.
Group II: PlaceboPlacebo Group1 Intervention
Identical IV solution without TB006 product
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TB006
2021
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Rossignol Medical CenterLead Sponsor
5 Previous Clinical Trials
766 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
766 Patients Enrolled for Autism Spectrum Disorder
Autism Discovery and Treatment FoundationUNKNOWN
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
1,000 Patients Enrolled for Autism Spectrum Disorder
Richard E Frye, M.D., Ph.DStudy DirectorRossignol Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
30 Patients Enrolled for Autism Spectrum Disorder
~30 spots leftby Dec 2025