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Suramin (KZ101) for Autism Spectrum Disorder in Boys

This study is looking into a drug called KZ101 (suramin) for boys aged 5 to 14 who have Autism Spectrum Disorder (ASD). Researchers want to see if KZ101 can help improve social skills. The study will compare KZ101 to a placebo (an inactive substance like normal saline). To join, boys must have a clinical diagnosis of ASD, meet certain scores on specific autism assessments (ADOS-2 and CGI-S), and have a non-verbal IQ above 70. The main way they will measure success is by looking at changes in social skills using a tool called Vineland-3 Socialization Domain, measured at different points during the study. The study plans to enroll 45 participants, but its current status is unclear.

Study design
This is a randomized, double-blind, crossover study, meaning participants will randomly receive either KZ101 or a placebo, and neither they nor the researchers will know which they are getting. There will be 45 participants across approximately 3 sites.
What's involved
After a screening period of up to 4 weeks, participants will receive 8 weeks of treatment, followed by an 8-week break, and then 8 more weeks of the other treatment. Dosing involves two intravenous (IV) infusions given 4 weeks apart in each treatment period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 weeks after completing the second treatment period.

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NCT06866275

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

Recruiting
PHASE2Ages 5–14InterventionalTreatment
Children's Hospital of Orange County
~45 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:KZ101Placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint - Vineland-3 Socialization Domain
Measured over Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).

Conditions

Autism Spectrum Disorder (ASD)

Explore related trials

Autism Spectrum Disorder

NCT06866275

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Orange County, Thompson Autism and Neurodevelopmental Center

    Orange, Californiastudy coordinator listed

    Recruiting

  • Kennedy Krieger Institute

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aram Kim, MD · PRINCIPAL_INVESTIGATOR · Thompson Autism and Neurodevelopmental Center, Children's Hospital of Orange County

Who to contact

Adrienne Moore, PhD
[email protected]
714-288-7456
Email the study team

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Eligibility criteria

Exclusion

Subjects who meet any of the following criteria will be excluded from the study.

What this trial measures

  • Primary Efficacy Endpoint - Vineland-3 Socialization DomainChange from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).

    The primary efficacy endpoint will be the change in standard score on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition (Vineland-3), which includes subdomains for coping skills, play skills, and interpersonal relation skills.