The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Treatment
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Dose Escalation to determine optimal dosage for clinical effects
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
Time frame: 6 weeks
Safety (AEs, ECG, laboratory parameters, physical examinations)
Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.
Time frame: 48 hours
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