ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)

Inclusion Criteria:

• Age 12 to 45 at screening

• Has a designated care/study partner who can reliably report on symptoms

• Has a diagnosis of Autism Spectrum Disorder (ASD)

• Has a body mass index (BMI) 18 through 34 kg/m², inclusive

• Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determinedby the Principal Investigator.

• Psychoactive medications and adjunctive therapies are stable for 4 weeks prior toscreening

• Must be able to swallow study medication

Exclusion Criteria:

• Has Rett syndrome or Child Disintegrative Disorder

• Has participated in any other study and received any other investigationalmedication (other than COVID-19 vaccination) or device within 60 days prior toscreening

• History of epilepsy without current adequate control, or any seizure in the 6 monthspreceding screening

• History of suicidal ideation or behavior in the past 12 months, or a positiveresponse to C-SSRS questions 4 and/or 5

• Systolic blood pressure ≥140 mmHg (if adult) or >135 mmHg (if adolescent), ordiastolic blood pressure ≥90 (if adult) or >85 mmHg (if adolescent), or a clinicalhistory of uncontrolled or severe hypertension

• If female, is pregnant or lactating