Who is eligible for clinical trial NCT06997484?

Participants must meet protocol criteria for Parkinson Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06997484 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-14

First-in-Human Single and Multiple Dose of HL-400 (NCT06997484)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Highlightll Pharmaceutical (USA) LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: Pharmaron CPC, Inc. — Baltimore, Maryland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Pharmaron CPC, Inc. — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗