New pill targets brain inflammation in Parkinson's – first human tests begin
NCT ID NCT06997484
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental oral drug called HL-400 in 86 healthy volunteers. The drug aims to block a protein (NLRP3) linked to inflammation, which may play a role in Parkinson's disease. The study focuses on safety, tolerability, and how the drug moves through the body, not yet on treating Parkinson's symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HL-400 (an oral NLRP3 inhibitor)
- What this could lead to
- If successful, this could pave the way for a new treatment that slows Parkinson's disease by targeting inflammation in the brain.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not Parkinson's patients. It only tests safety and dosing, not whether the drug works for the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pharmaron CPC, Inc.
RECRUITINGBaltimore, Maryland, 21201, United States
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