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Recruiting NCT06997484

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

Phase I Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HL-400, Placebo.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug HL-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.
  • Drug Placebo
    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.

Primary outcome measures

  • Number and percentage of participants with adverse events (AEs) [Time frame: 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 [Time frame: 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 [Time frame: From baseline to 7 days after the last dose.]
  • Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400 [Time frame: 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 [Time frame: From 0.5 hour to 72 hours post-dose.]
  • Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400 [Time frame: From 0.5 hour to 72 hours post-dose.]
  • Single Ascending Dose (SAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400 [Time frame: From 0.5 hour to 72 hours post-dose.]
  • Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400 [Time frame: From Day 1 pre-dose to 72 hours after the last dose.]
  • Multiple Ascending Dose (MAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400 [Time frame: From Day 1 pre-dose to 72 hours after the last dose.]
Secondary outcome measures (2)
  • 1.The cerebrospinal fluid (CSF) cohort: Maximum observed concentration (Cmax) of HL-400 in the CSF [Time frame: 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 [Time frame: From Day 1 pre-dose to 24 hours after the last dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Pharmaron CPC, Inc. — Baltimore

Identifiers

NCT: NCT06997484 · HL-400-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗