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

Inclusion Criteria:

• Subject must meet all of the following criteria to be enrolled in this study.

1. Male, aged 5-14 years

2. Clinical diagnosis of ASD by DSM-5 criteria

3. ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2years).

4. CGI-S ≥ 4 for socialization specific symptoms of ASD

5. Leiter-3 non-verbal IQ > 70

6. Standard score < 75 on the Socialization Domain of the Comprehensive Interview Formof the Vineland Adaptive Behavior Scale Third Edition

7. Subjects who are sexually active or potentially sexually active agree to use condomswith a spermicidal as a barrier method of contraception during the treatment periodand for at least 30 days after the last dose of study medication

8. Subjects agree to wear sunscreen and to wear skin covering to the maximal degreetolerated by the child for the duration of the treatment period and for at least 30days after the last dose of study medication

9. Subjects must have a ≤ 90 minutes car ride from the study site

10. English-speaking child and parent/guardian or caregiver

11. Parent or their legal guardians must be willing to sign informed consent

Exclusion Criteria:

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

1. ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman,Down's Syndrome, etc.)

2. ≤ 5th percentile for weight

3. Unable to tolerate venipuncture or urine collection

4. Acute infection (e.g., upper respiratory tract infection, common cold, flu,strep, COVID-19)

5. Severe co-morbid conditions (e.g., psychosis, seizures/epilepsy uncontrolled bymedication, presence of severe visual or hearing impairment) that may interactwith study procedures. Controlled epilepsy is allowed providing there has notbeen a breakthrough seizure in the past year.

6. Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x theupper limit of normal), kidney (estimated glomerular filtration rate or eGFR < 90 mL/min/1.73 m2; hematuria confirmed by urine microscopy [ > 5 red bloodcells/high power field]; proteinuria [> 1+ that does not resolve on repeattesting or urine protein to creatinine ratio > 0.3]; and/or presence of anygranular, mixed cellular, red blood cell, white blood cell, or muddy browncasts on urine microscopy), or clinically relevant heart or adrenalabnormalities

7. Hospitalization within the previous 2 months from screening

8. Initiation or change in pharmacotherapy within previous 2 months from screening

9. Initiation or change in psychosocial interventions (formal behavioral,cognitive, or cognitive-behavior therapy) within previous 2 months fromscreening

10. Plan to initiate or change pharmacotherapy or psychosocial interventions duringthe study

11. Taking prescription medication that may interact adversely with KZ101 or exposethe subject to increased risk of harm such as medications with plasma boundsubstances including sulfonamides, chlorpromazine, and anti-coagulants

12. Currently enrolled in another clinical study or has received anyinvestigational treatment within 30 days of screening

13. Taking > 3 medications addressing behavioral symptoms related to ASD (ietypical/atypical antipsychotics and alpha-adrenergic agonists) or comorbidmedical conditions such as ADHD, anxiety, or depression. Anti-seizuremedications and other medications not related to neurobehavioral symptoms donot count towards the total number of medications allowed.

14. History of serious dermatological reactions

15. History of allergy, intolerance, or photosensitivity to any drug

16. Unable or unwilling to adhere to study requirements