Tests an investigational drug for autism in adults

Trial details

Who runs it

Rossignol Medical Center

Trial code

NCT06500637

Record updated

14 April 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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; 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%); 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; 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.

ClinicalTrials.gov NCT06500637