Recruiting
Phase 1

HL-400

Sponsor:

Highlightll Pharmaceutical (USA) LLC

Code:

NCT06997484

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

HL-400

Placebo

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06997484

Start date

Apr 25, 2025

Status verified date

Apr, 2026

Completion date

Oct 27, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

86 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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, once a day (QD) for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.

placebo comparator: 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

Interventions

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.

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 measure

  • 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. ]

Central Contacts and Locations

Locations

Pharmaron CPC, Inc.

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kristin M. Satterfield, MD,PhD

240-673-0500kristin.satterfield@pharmaron.com

More Information

Sponsor

Highlightll Pharmaceutical (USA) LLC

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Highlightll Pharmaceutical (USA) LLC on 2026-04-17.