TB006 for Autism Spectrum Disorder

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Rossignol Medical Center
Study ID
NCT06500637
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • TB006 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Aug 3, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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). 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.
  • Placebo Comparator: Placebo
    Identical IV solution without TB006 product

Primary Outcome Measure

Childhood Autism Rating Scores (CARS) [ Time Frame: Baseline, Week 8 and Week 14 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rossignol Medical CenterPhoenixArizona85050
Richard E Frye, M.D., PhD
[email protected]
321-259-7111
Richard E Frye, M.D., PhD (PRINCIPAL_INVESTIGATOR)
Rossignol Medical CenterAliso ViejoCalifornia92656
Desiree Chandler, PA
[email protected]
321-259-7111

Find similar trials in Phoenix, AZ

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Rossignol Medical Center· Phoenix, AZRossignol Medical Center· Aliso Viejo, CA

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