HL-400 Trial
Phase 1
54
about 10 months
18–65
1 site in MD
What this study is about
Researchers are testing a new drug called HL-400 in people with Parkinson's Disease. The trial will evaluate the safety and how the body processes HL-400 after taking it as a single dose or multiple doses over 308 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take HL-400
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline, Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400, Number and percentage of adverse events (AEs) according to severity, Number and percentage of participants with adverse events (AEs), Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400, Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400, Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400
Secondary: 1.The cerebrospinal fluid (CSF) cohort: Maximum observed concentration (Cmax) of HL-400 in the CSF
Neurology