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HL-400 for Parkinson's Disease

This study is testing a new drug called HL-400, which is an NLRP3 inhibitor, to see how safe it is and how your body handles it. Researchers will give participants either HL-400 or a placebo (an inactive substance that looks like the drug) in single or multiple doses. The main goal is to track any side effects and changes in your heart's electrical activity. This study is for healthy individuals between 18 and 65 years old. The trial aims to enroll 86 participants, but its current status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with healthy participants, designed to test increasing doses of HL-400. It plans to enroll 86 people.
What's involved
Participants will receive single or multiple oral doses of HL-400 or placebo. This involves taking the study drug for up to 14 days, and attending follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and heart changes for up to 7 days after their last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06997484

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Highlightll Pharmaceutical (USA) LLC
~86 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:HL-400Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants with adverse events (AEs)
Measured over From the time of taking first dose of study drug to 7 days after the last dose.
+8 more outcomes measured

Conditions

Parkinson Disease

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Maryland1

Who to contact

Kristin M. Satterfield, MD,PhD
[email protected]
240-673-0500 · ext. 1734
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number and percentage of participants with adverse events (AEs)From the time of taking first dose of study drug to 7 days after the last dose.

    To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.

  • Number and percentage of adverse events (AEs) according to severityFrom the time of taking first dose of study drug to 7 days after the last dose.

    To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.

  • Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baselineFrom baseline to 7 days after the last dose.

    To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.

  • Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400From 0.5 hour to 72 hours post-dose.

    To characterize the PK in the plasma of HL-400 following oral single dose administration.

  • Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400From 0.5 hour to 72 hours post-dose.

    To characterize the PK in the plasma of HL-400 following oral single dose administration.

  • Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400From 0.5 hour to 72 hours post-dose.

    To characterize the PK in the plasma of HL-400 following oral single dose administration.

  • Single Ascending Dose (SAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400From 0.5 hour to 72 hours post-dose.

    To characterize the PK in the plasma of HL-400 following oral single dose administration.

  • Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400From Day 1 pre-dose to 72 hours after the last dose.

    To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.

  • Multiple Ascending Dose (MAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400From Day 1 pre-dose to 72 hours after the last dose.

    To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.