RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests HL-400, a medicine taken by mouth, in healthy adults ages 18 to 65. It compares single and repeated doses at increasing amounts with a placebo, which has no active medicine. Researchers will check safety, side effects, and how the body handles HL-400.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can give written consent and follow all study visits, rules, and procedures.
  • Are 18 to 65 years old at screening.
  • Women must have negative pregnancy tests at screening and the day before dosing, follow the study’s birth control rules, and not donate eggs for at least 3 months after the last dose.
  • Men with partners who could become pregnant must avoid sex or use a condom plus another barrier birth control method used by their partner during the study and for at least 3 months after the last dose. Men must not donate sperm for at least 3 months after the last dose.
  • Are judged healthy by the study doctor based on health history, an exam, blood and other lab tests, a heart rhythm test, and vital signs.
  • Have not smoked for at least 6 months before screening.
  • Have a body mass index (BMI), a measure of weight compared with height, of 18 to 32. For group 3 of the repeated-dose part, BMI must be 32 to 42.

Who can't join

  • Have a major past or current health problem, as judged by the study doctor, involving digestion, the heart, muscles or bones, hormones, blood, mental health, kidneys, liver, lungs, nerves, the immune system, how the body handles fats, or drug allergies.
  • Are pregnant or breastfeeding.
  • Have a history of long-term diarrhea, trouble absorbing nutrients, unexplained weight loss, food allergies, or trouble tolerating foods.
  • Have a positive blood screening test for HIV, hepatitis B, or hepatitis C.
  • Test positive for alcohol or drugs of abuse at screening or the day before dosing.
  • Cannot or will not follow the study’s food and drink rules.
  • Took part in a study of an experimental drug or device within 3 months before dosing.
  • Have any condition or test finding that the study doctor thinks could put you or the study at risk.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD