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TB006 for Autism Spectrum Disorder

NCT06500637 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-14

No results posted yet for this study

Summary

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

Interventions

DRUG

TB006

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).

Sponsors & Collaborators

  • Autism Discovery and Treatment Foundation

    collaborator UNKNOWN

  • Rossignol Medical Center

    lead OTHER

Principal Investigators

  • Richard E Frye, M.D., Ph.D · Rossignol Medical Center

  • Daniel A Rossignol, MD · Rossignol Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500637 on ClinicalTrials.gov