Testing HL-400 for safety and tolerability in healthy volunteers
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
This study is testing a new drug called HL-400 in healthy volunteers to see if it's safe and how well it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Highlightll Pharmaceutical (USA) LLC Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06997484 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of HL-400, a NLRP3 inhibitor, in healthy subjects through a randomized, double-blind, placebo-controlled, dose-escalation approach. It consists of three parts: a single ascending dose, multiple ascending doses, and assessment of cerebrospinal fluid exposure. Participants will undergo various assessments to monitor safety and relevant biomarkers throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 who can comply with study procedures.
Not a fit: Patients with existing health conditions or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for Parkinson's disease by providing insights into the safety and pharmacokinetics of HL-400.
How similar studies have performed: Other studies involving NLRP3 inhibitors have shown promise, but this specific approach is novel and untested in humans.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Pharmaron CPC, Inc. — Baltimore, Maryland, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.