HL-400 for Parkinson Disease

At a Glance

Age: 18 – 65
Sex: Any
Trial phase: Phase 1
Study type: Interventional
Purpose: Treatment
Participants needed: 86 (estimated)
Sponsor: Highlightll Pharmaceutical (USA) LLC · Industry

Who this trial is looking for

This trial is looking for healthy adults aged 18 to 65 to test a new drug called HL-400 for Parkinson's disease. Participants will take the drug and be monitored for safety and how their body processes it.

Are You a Good Fit for This Trial?

You may be able to join if

I am between 18 and 65 years old.
I can give written consent and follow study rules.
I do not smoke.
My body mass index (BMI) is 18.0 to 32.0, or I am in a specific group with a BMI of up to 42.0.
I agree to use contraception if I am a woman or if I am a man with a female partner.
I have a negative pregnancy test if I am female.

You may not be able to join if

I have a significant health condition, like heart or kidney disease.
I am pregnant or breastfeeding.
I have a history of food allergies or unexplained weight loss.
I have tested positive for HIV, hepatitis B, or hepatitis C.
I have a positive screen for alcohol or drugs.
I cannot follow food and drink rules during the trial.
I have participated in another clinical trial in the last 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About 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.

Trial Locations

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Eligibility 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 andD…

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.

Contacts

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HL-400 for Parkinson Disease

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