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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Children's Hospital of Orange County
Study ID
NCT06866275
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex
MALE
Age
5 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • KZ101 — DRUG
    For active treatment with KZ101, a loading dose of 454 mg/m2 (salt-free) will be followed by a treatment dose of 363 mg/m2 (salt-free).
  • Placebo — DRUG
    Dosing in the placebo group will consist of a volume of normal saline equivalent to that given during the active treatment period for each participant.

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Drug followed by Placebo
  • Placebo Comparator: Placebo followed by Drug

Primary Outcome Measure

Primary Efficacy Endpoint - Vineland-3 Socialization Domain [ Time Frame: Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout). ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Southwest Autism Research and Resource CenterPhoenixArizona85006
Padmaja Lakamsani
[email protected]
602-340-8717
Christopher J Smith, PhD (PRINCIPAL_INVESTIGATOR)
Children's Hospital Orange County, Thompson Autism and Neurodevelopmental CenterOrangeCalifornia92868
Adrienne R Moore, PhD
[email protected]
714-288-7456
Aram Kim, MD (PRINCIPAL_INVESTIGATOR)
Kennedy Krieger InstituteBaltimoreMaryland21205
Katie Kay
[email protected]
443-923-3819
Karen Chen
[email protected]
667-205-4393
Stephanie Morris, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Southwest Autism Research and Resource Center· Phoenix, AZChildren's Hospital Orange County, Thompson Autism and Neurodevelopmental Center· Orange, CAKennedy Krieger Institute· Baltimore, MD

Related Studies