Parkinson DiseasePhase 1NCT06997484
First-in-Human Single and Multiple Dose of HL-400
A Phase 1 study testing HL-400 in people with Parkinson Disease, run by Highlightll Pharmaceutical (USA) LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- HL-400
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2025to 27 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pharmaron CPC, Inc.
Baltimore, Maryland, 21201
Kristin M. Satterfield, MD,PhD, 240-673-0500 ext. 1734, kristin.satterfield@pharmaron.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics of HL-400 Following Oral Administration
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 following oral single and multiple ascending dose administration.This study will consist of 3 parts, which are Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) and Part3 (cerebrospinal fluid (CSF) Exposure).
Safety, pharmacokinetic parameters and relevant biomarkers will be assessed in the study.
- Conditions
- Parkinson Disease
- Being tested
- HL-400, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-400Drug
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, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HL-400 | Active comparator | 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. Receives: Drug: HL-400 |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with adverse events (AEs)
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Measured: From the time of taking first dose of study drug to 7 days after the last dose.
Number and percentage of adverse events (AEs) according to severity
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Measured: From the time of taking first dose of study drug to 7 days after the last dose.
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Measured: From baseline to 7 days after the last dose.
Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Measured: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Measured: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Measured: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Measured: From 0.5 hour to 72 hours post-dose.
Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.
Measured: From Day 1 pre-dose to 72 hours after the last dose.
Multiple Ascending Dose (MAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.
Measured: From Day 1 pre-dose to 72 hours after the last dose.
Secondary outcomes (2)
1.The cerebrospinal fluid (CSF) cohort: Maximum observed concentration (Cmax) of HL-400 in the CSF
To characterize the PK in the CSF of HL-400 following oral multiple dose administration.
Measured: From Day 1 pre-dose to 24 hours after the last dose
The cerebrospinal fluid (CSF) cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400 in the CSF
To characterize the PK in the CSF of HL-400 following oral multiple dose administration.
Measured: From Day 1 pre-dose to 24 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start25 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Highlightll Pharmaceutical (USA) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997484
- Sponsor's protocol ID
- HL-400-101
- Status last verified
- Apr 2026
- First submitted
- 13 May 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics of HL-400 Following Oral Administration
- ClinicalTrials.gov ID
- NCT06997484
- Acronym / sponsor ID
- HL-400-101
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Highlightll Pharmaceutical (USA) LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 following oral single and multiple ascending dose administration.This study will consist of 3 parts, which are Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) and Part3 (cerebrospinal fluid (CSF) Exposure).
Safety, pharmacokinetic parameters and relevant biomarkers will be assessed in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL-400 | Active comparator | Drug: HL-400Part 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. |
| Placebo | Placebo comparator | Drug: PlaceboPart 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL-400Part 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, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days. | Drug | HL-400 |
| PlaceboPart 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. | Drug | Placebo |
Primary outcome
Number and percentage of participants with adverse events (AEs)
Time frame: From the time of taking first dose of study drug to 7 days after the last dose.
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Number and percentage of adverse events (AEs) according to severity
Time frame: From the time of taking first dose of study drug to 7 days after the last dose.
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Time frame: From baseline to 7 days after the last dose.
To evaluate the safety and tolerability of HL-400 following oral single and multiple ascending dose administration.
Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
Time frame: From 0.5 hour to 72 hours post-dose.
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400
Time frame: From 0.5 hour to 72 hours post-dose.
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400
Time frame: From 0.5 hour to 72 hours post-dose.
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Single Ascending Dose (SAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
Time frame: From 0.5 hour to 72 hours post-dose.
To characterize the PK in the plasma of HL-400 following oral single dose administration.
Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
Time frame: From Day 1 pre-dose to 72 hours after the last dose.
To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.
Multiple Ascending Dose (MAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
Time frame: From Day 1 pre-dose to 72 hours after the last dose.
To characterize the PK in the plasma of HL-400 following oral multiple ascending dose administration.
2 secondary outcomes
1.The cerebrospinal fluid (CSF) cohort: Maximum observed concentration (Cmax) of HL-400 in the CSF
Time frame: From Day 1 pre-dose to 24 hours after the last dose
The cerebrospinal fluid (CSF) cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400 in the CSF
Time frame: From Day 1 pre-dose to 24 hours after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL-400 in people with Parkinson Disease, run by Highlightll Pharmaceutical (USA) LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with adverse events (AEs) (time frame: From the time of taking first dose of study drug to 7 days after the last dose.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.