RecruitingPhase 1NCT06997484

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

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics of HL-400 Following Oral Administration

Sponsor

Highlightll Pharmaceutical (USA) LLC

Enrollment

54 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

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 Criteria8

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.

Interventions

DRUGHL-400

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.

DRUGPlacebo

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.