Phase I/II Single Center, Open-Label Study Examining Image Result for Pharmacokinetics of 2 Modified-Release Formulations of MPH in Adolescent/Pediatric With ADHD

Both stages of this study will be divided into two phases: Screen and Active Period. During
Screen, subjects will be screened over the course of 14 days, and washed off their existing
ADHD medication during the final 5 days of outpatient screening. During the active period,
subjects will receive a single treatment of B-HLD200 and plasma samples for PK will be
collected during the night and through the next 48 hours. In addition, pediatric subjects
will undergo math testing using the pen-and-paper PERMP both prior to and post dosing. This
study procedure will be carried out across three sequential groups of 6 subjects until the
full B-HLD200 formulation cohort of 18 subjects have completed all study procedures.
Following the first cohort of 18 subjects, the entire sequence may be repeated in second
subject cohort tested with C-HLD200.

Inclusion Criteria:

- Male and female adolescents (13-17 years; Stage 1) and children (6-12 years; Stage 2).

- Previous diagnosis of ADHD and confirmation using the Mini International
Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

- ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on
MPH or have previous history of symptom control during treatment with MPH.

- Physical examination free of clinically significant findings, unless deemed NCS by the
Investigator and Medical Monitor;

- Able to swallow treatment capsules;

- Available for entire study period;

- Provision of informed consent (from the parent[s] and/or legal representative[s]) and
assent (from the subject); and

- Female subjects of childbearing potential (i.e., post-menarche) required to have a
negative result on urine pregnancy testing (and will be given specific instructions on
avoiding pregnancy during trial)

Exclusion Criteria:

- Any known history or presence of significant cardiovascular, pulmonary, hepatic,
renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
neurologic, ophthalmologic disease, unless deemed NCS by the Investigator and the
Medical Monitor;

- Presence of any significant physical or organ abnormality;

- Any illness during the 4 weeks before this study, unless deemed NCS by the
Investigator and the Clinical and/or Medical Monitor;

- Severe comorbid psychiatric diagnosis that may affect subject safety or confound
results (e.g., psychosis, bipolar disorder);

- Known history of moderate to severe asthma;

- Known history of severe allergic reaction (including drugs, food, insect bites,
environmental allergens);

- 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.

- Clinical value outside of the acceptable ranges, unless deemed NCS significant per the
Investigator;

- Positive history for hepatitis B, hepatitis C and 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 and/or Medical
Monitor;

- Blood draws of 50 ml to 249 ml within the 30 days, 250 ml to 449 ml within the 45 days
and ≥ 450 ml within the 60 days preceding study enrollment;

- Participation in clinical trial with an investigational drug within the 30 days
preceding study enrollment;

- Intolerance to venipuncture; and

- Current suicidal ideation or history of suicidality determined as a significant
finding on the Columbia-Suicide Severity Rating Scale (C-SSRS) by the investigator
(Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).