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Study identifier: NCT06866275 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)

Condition: Autism Spectrum Disorder (ASD)  ·  Sponsor: Children's Hospital of Orange County

PhasePhase 2
Planned participants45
Who can joinMale, 5 Years to 14 Years
Healthy volunteersNo

About this study

Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.

This description comes directly from the study's public registry record.

Talk to the study team

Adrienne Moore, PhD  ·  714-288-7456  ·  adrienne.moore@choc.org

Always discuss trial participation with your own doctor first.

Locations (2)

Children's Hospital Orange County, Thompson Autism and Neurodevelopmental CenterOrange, California, United StatesRecruiting
Kennedy Krieger InstituteBaltimore, Maryland, United StatesRecruiting

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