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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests HL-400, a new treatment that blocks a specific protein (NLRP3) to determine its safety and tolerance in healthy individuals. Participants will take either HL-400 or a placebo (a harmless pill with no active drug) in varying doses to observe the body's response. The trial targets non-smoking individuals who are generally healthy, have not experienced significant health issues, and fall within a specific weight and body mass index (BMI) range. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy subjects, it might imply that participants should not be on any regular medications. Please consult with the study team for clarification.

Is there any evidence suggesting that HL-400 is likely to be safe for humans?

A previous study tested HL-400, a type of drug known as a NLRP3 inhibitor, to assess its safety. As a Phase 1 trial, HL-400 is in the early stages of human testing. The primary focus at this stage is identifying any side effects and evaluating how well participants tolerate the drug.

Specific data from past tests on HL-400's safety is not yet available. However, Phase 1 trials typically proceed with caution, starting with low doses and closely monitoring for any issues. This careful approach ensures the drug's safety before broader testing. Testing in healthy individuals, rather than patients, suggests a low risk of severe side effects at this stage.

The goal is to determine HL-400's safety and behavior in the body. While no clear evidence of harm has emerged, the full safety profile is still under development as testing continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HL-400 because it offers a novel approach to treatment with its unique delivery method and dosing schedule. Unlike many current treatments that often require more complex administration, HL-400 is administered orally, making it more convenient for patients. Additionally, the treatment involves both single and multiple ascending doses, potentially allowing for tailored dosing strategies that could enhance effectiveness and minimize side effects. This streamlined and flexible approach could offer significant advantages over existing options.

What evidence suggests that HL-400 might be an effective treatment as an NLRP3 inhibitor?

Research shows that HL-400 is a new drug designed to block a protein called NLRP3, which contributes to inflammation. Early tests in labs and animals have demonstrated that targeting NLRP3 can effectively reduce inflammation. Although human studies on HL-400 are limited, the underlying science is promising. Similar drugs targeting NLRP3 have yielded positive results in reducing inflammation in other research. This positions HL-400 as a potential option for treating inflammation-related conditions. Participants in this trial will receive either HL-400 or a placebo to assess its safety and effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

Volunteers who have participated in any investigational drug or device study within past 3 months prior to dosing

A positive screen for alcohol or drugs of abuse at screening or Day -1

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-1-parkinson-disease-3-2025-2898e

HL-400 for Safety Evaluation This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of ...

2. trial.medpath.com trial.medpath.com/clinical-trial/24230f18491412a2/nct06997484-hl-400-safety-tolerability-pharmacokinetics-healthy-subjects

First-in-Human Single and Multiple Dose of HL-400 | MedPath This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914087/

Preclinical Evaluation of Safety, Pharmacokinetics, Efficacy ... These results show that HL-003 is a radioprotective agent with a favorable safety profile, high efficacy, oral administration, and a long half- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05008224

NCT05008224 | Study of Safety and Efficacy ... The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/217865Orig1s000IntegratedR.pdf

217865Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov ... data from the phase 2 study (Study 43) and clinical safety and efficacy data from across the givinostat development program in other.

6. scribd.com scribd.com/document/416160103/000044eb-1

Safety: Data Sheet | PDF | Firefighting | Polyvinyl Chloride This document provides a safety data sheet for VORALUX* HL 400 Polyol. It lists the product name and manufacturer identification.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200021B.pdf

Summary of Safety and Effectiveness Data (SSED) Stress Relief of. Junctions in. Implantable Leads. To evaluate the resistance to stress of the junctions of the implantable leads of the Neuro Zti Implant.

8. sciencedirect.com sciencedirect.com/science/article/am/pii/S0951832021005512

Guided simulation for dynamic probabilistic risk ... Guidelines on modeling commoncause failures in probabilistic risk assessment. Safety Programs Division, Office for Analysis and Evaluation of Operational Data, ...

9. download.basf.com download.basf.com/p1/000000000030784920_SDS_CPA_00/en_UN/Ilevo_HL_Seed_Treatment_30784920_SDS_CPA_00_en_1-0.pdf

Ilevo HL Seed Treatment H400. Very toxic to aquatic life. H301. Toxic if swallowed. H314. Causes severe ... This safety data sheet is neither a. Certificate of Analysis (CoA) nor ...