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

Highlightll Pharmaceutical (USA) LLC

Status and phase: Enrolling; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: HL-400; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06997484

HL-400-101

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending dose administration.

Full description

This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 following oral single and multiple ascending dose administration.This study will consist of 3 parts, which are Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) and Part3 (cerebrospinal fluid (CSF) Exposure).

Safety, pharmacokinetic parameters and relevant biomarkers will be assessed in the study.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 and body weight not less than 50 kg.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

HL-400

Active Comparator group

Description:

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.

Treatment:

Drug: HL-400

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo