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NCT06997484 | RECRUITING | Parkinson Disease

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

Highlightll Pharmaceutical (USA) LLC

Brief 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.

Condition or disease

Parkinson Disease

Intervention/treatment

HL-400

Placebo

Phase

PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-04-25
Estimated Primary Completion Date : 2026-01-30
Estimated Study Completion Date : 2026-02-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 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.
First-in-Human Single and Multiple Dose of HL-400

Location Details

NCT06997484

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How to Participate

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Locations

RECRUITING

United States, Maryland

Pharmaron CPC, Inc.

Baltimore, Maryland, United States, 21201