First-in-Human Single and Multiple Dose of HL-400 | NCT06997484

NCT06997484

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HL-400	Active Comparator	Part 1:Experimental: Single oral dose of HL-400, Single ascending doses, sequential assignment group design; Part 2: Experimental: Multiple oral doses of HL-400, Multiple ascending doses, once a day (QD) for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.	Drug: HL-400
Placebo	Placebo Comparator	Part 1: Placebo comparator: Single oral dose of placebo, single doses, matching placebo; Part 2: Placebo comparator: Multiple oral doses of placebo, multiple ascending doses, QD for 14 days, matching placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HL-400	Drug	Part 1:Experimental: Single oral dose of HL-400, Single ascending doses, sequential assignment group design; Part 2: Experimental: Multiple oral doses of HL-400, Multiple ascending doses, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and percentage of participants with adverse events (AEs)	To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.	From the time of taking first dose of study drug to 7 days after the last dose.
Number and percentage of adverse events (AEs) according to severity	To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.	From the time of taking first dose of study drug to 7 days after the last dose.
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline	To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.	From baseline to 7 days after the last dose.
Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400	To characterize the PK in the plasma of HL-400 following oral single dose administration.	From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400	To characterize the PK in the plasma of HL-400 following oral single dose administration.	From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400	To characterize the PK in the plasma of HL-400 following oral single dose administration.

Secondary Outcomes

Measure	Description	Time Frame
1.The cerebrospinal fluid (CSF) cohort: Maximum observed concentration (Cmax) of HL-400 in the CSF	To characterize the PK in the CSF of HL-400 following oral multiple dose administration.	From Day 1 pre-dose to 24 hours after the last dose
The cerebrospinal fluid (CSF) cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400 in the CSF

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are capable of giving written informed consent and complying with study procedures, schedule, requirements, and restrictions.
Are between the ages of 18 and 65 years, inclusive, at screening.
Female subjects have a negative serum hCG pregnancy test result at screening andDay （-1）, agree to refrain from ova donation for at least 3 months after the last dose, and willingness to comply with protocol-specified contraceptive methods.
Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 3 months after last dosing; must also agree to refrain from sperm donation for at least 3 months after the last dose.
Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
Non-smoker for at least 6 months prior to screening.
Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive, except for MAD Cohort 3 subjects with a BMI of of 32.0 to 42.0 kg/m2 inclusive.

Exclusion Criteria:

Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator.
Pregnant (as determined by pregnancy test result) or breastfeeding women.
History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance.
Positive blood screen for human immunodeficiency virus (HIV 1/2), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
A positive screen for alcohol or drugs of abuse at screening or Day -1.
An unwillingness or inability to comply with food and beverage restrictions during study participation.
Volunteers who have participated in any investigational drug or device study within past 3 months prior to dosing.
Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases