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

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with 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 determined by the Principal Investigator. * Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening * 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 investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening * History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening * History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5 * Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension * If female, is pregnant or lactating