NCT06997484 · Highlightll Pharmaceutical (USA) LLC
First-in-Human Single and Multiple Dose of HL-400
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, gradually increasing doses study in healthy subjects to evaluate the safety, tolerability, how the drug moves through the body of HL-400 (a NLRP3 inhibitor) following taken by mouth single and multiple ascending dose administration.
View original scientific description
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.
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.
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 severity
Time frame: 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.
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.
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-400
Time frame: From 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-400
Time frame: From 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-400
Time frame: From 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-400
Time frame: From 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-400
Time frame: From 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-400
Time frame: From 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations