A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD

This dose-escalation study will examine HLD100 in 24 subjects.

The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.

This study will be divided into several phases: Screening, Active Treatment and Follow-Up.
All visits have a 2 day window to allow for scheduling.

Inclusion Criteria:

- Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation
using the Mini International Neuropsychiatric Interview for Children and Adolescents
(MINI-KID).

- Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function
per the following at screening (V1) and/or baseline (V2):

- ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in
total score and ≥24 at Baseline;

- CGI-S score ≥4;

- Subject body weight must be ≥20 kg.

- Subject must be considered clinically appropriate for treatment with amphetamine and
HLD100, including prior treatment experience with an amphetamine product, and ability
to swallow treatment capsules.

Exclusion Criteria:

- History of, or current, medical condition or laboratory result which, in the opinion
of the investigator, unfavorably alters the risk-benefit of study participation, may
jeopardize subject safety, or may interfere with the satisfactory completion of the
study and study-related procedures.

- Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm
abnormalities, or other cardiac problems that may place the subject at increased
vulnerability to the sympathomimetic effects of a stimulant drug.

- History of seizure disorder (except febrile seizures prior to age 5 and with last
occurrence at least 1 year prior to study participation), Tourette's disorder, or
intellectual disability of minor severity or greater (DSM-5 criteria).

- History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt.
Current depression, anxiety, conduct/behavior disorder, substance use disorder, or
other psychiatric condition which, in the investigator's opinion, may jeopardize
subject safety or may interfere with the satisfactory completion of the study and
study-related procedures.

- Active suicidal ideation as evidenced by an ideation score of 2 or greater on the
C-SSRS.

- History of severe allergic reaction or intolerance to amphetamine.