HL-400 for Safety Evaluation

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Highlightll Pharmaceutical (USA) LLC

Must not be taking: Alcohol, Drugs of abuse

Disqualifiers: Gastrointestinal, Cardiovascular, Psychiatric, others

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to test the safety of a new Parkinson's disease drug called HL-400. Specific eligibility criteria are not provided, but typically participants should have no significant health issues that could interfere with the trial.

Inclusion Criteria

I can sign and follow the study's rules and visits.

I am between 18 and 65 years old.

Non-smoker for at least 6 months prior to screening

Exclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single oral dose of HL-400 with dose escalation to evaluate safety, tolerability, and pharmacokinetics

Up to 72 hours post-dose

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple oral doses of HL-400 once daily for 14 days to evaluate safety, tolerability, and pharmacokinetics

14 days

Daily visits for dose administration and monitoring

Cerebrospinal Fluid (CSF) Exposure

Participants receive multiple oral doses of HL-400 to evaluate pharmacokinetics in the CSF

5 days

Daily visits for dose administration and CSF sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days after the last dose

Treatment Details

Interventions

• HL-400

Trial Overview The study tests HL-400, an oral medication intended for Parkinson's disease, against a placebo. It's designed to see how safe it is and how the body reacts to different doses over time. Participants will be randomly assigned to either receive HL-400 or a placebo without knowing which one they're getting.

Participant Groups

Group I: HL-400 Active Control 1 Intervention

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, once a day (QD) for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Highlightll Pharmaceutical (USA) LLC

Lead Sponsor