A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

Exclusion Criteria

• •Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease
• •Presence of any significant physical or organ abnormality
• •Any illness during the 4 weeks before this study
• •Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)
• •Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled
• •Known history of severe allergic reaction to MPH
• •Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder
• •Subject who are severely underweight or overweight (in the opinion of the Investigator)
• •Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator
• •Positive history for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)
• •Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject
• •Use of prescription medications (except ADHD medications) within 7 days and over-the-counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical or Medical Monitor
• •Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment
• •Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).