NCT06997484RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 13 May 2025
- Start date
- 25 Apr 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Highlightll Pharmaceutical (USA) LLC
- Diseases
- Parkinson disease
- NCT number
- NCT06997484
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 86
- From 25 Apr 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A positive screen for alcohol or drugs of abuse at screening or Day -1.
- Volunteers who have participated in any investigational drug or device study within past 3 months prior to dosing.
Other illness
- 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.
- 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.
- 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.
Other
- Pregnant (as determined by pregnancy test result) or breastfeeding women.
- An unwillingness or inability to comply with food and beverage restrictions during study participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pharmaron CPC, Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.