Healthy ParticipantsPhase 1NCT07671833
A Study of LY03015 in Healthy Chinese and Caucasian Adult Subjects
A Phase 1 study testing LY03015 (LPM3770164 extended-release tablets) in people with Healthy Participants, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
This is an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- LY03015 (LPM3770164 extended-release tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 27 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years, inclusive.
- In good health, based on detailed medical history, clinical laboratory tests, vital signs, physical examinations, and ECGs per Investigator's judgment.
- Body mass index (BMI) is between 18.5 and 28 kg/m2, inclusive, and body weight ≥ 50 kg at screening.
- Specific ethnicity:
- Chinese participant: born in China to Chinese parents, with both maternal and paternal grandparents must not have lived outside of China for more than 5 years, and lifestyle, including dietary habits, must have remained largely unchanged since relocating from China.
- Caucasian participant: born of Caucasian parents and both maternal and paternal grandparents must have largely maintained their usual lifestyle and diet.
- All female subjects must have a negative pregnancy test result at both screening and baseline. If of childbearing potential (WOCBP) and heterosexually active, practicing or agree to practice a highly effective contraception method of birth control. Highly effective methods of birth control must be used for at least 21 days prior to study drug dosing, throughout the study, and for at least 30 days after dosing to minimize the risk of pregnancy.
- Sexually active fertile male subjects must be willing to use acceptable contraception methods from study drug dosing, throughout the study, and for at least 30 days after dosing if their partners are women of child-bearing potential.
Who cannot join
- Known history of hypersensitivity to VMAT2 inhibitors; or allergic to any ingredient of the investigational drug.
- Clinically significant past medical history in the judgement of the Investigator, would interfere with the subject's ability to participate in the study.
- History of depression, akathisia, agitation, restlessness, parkinsonism, or neuroleptic malignant syndrome (NMS).
- History of suicide attempts in the past 12 months and/or evident history of risk of suicide or homicide as assessed by the Investigator.
- Known history of gastric ulceration or gastrointestinal bleeding; or inability to swallow the study drug or having gastrointestinal dysfunction that, in the Investigator's judgment, would affect drug absorption.
- Known history or current substance abuse including alcohol, nicotine, and illegal drugs; urine drug screen or alcohol test positive at screening or baseline.
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- Known history of syncope during blood draws or injections, or inability to tolerate intravenous paracentesis.
- Malignancies within 5 years with exception of cured basal cell or squamous cell skin cancer prior to screening.
- Clinically significant abnormal findings in vital signs, laboratory tests, and
- ECGs at screening or baseline, including but not limited to:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN);
- Serum creatinine > ULN;
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m²;
- QT interval corrected by Fridericia's formula (QTcF) >450 msec for males and >460 msec for females; or a prior history or presence of circumstances that could increase the risk of torsade de pointes or sudden death in association with the use of study drug that prolong the QTc interval, or other clinically significant ECG findings upon the Investigator's decision.
- Use of any prescription medications within 28 days prior to dosing; use of any Over- the-counter (OTC) medications including herbal supplements, minerals, and vitamins within 7 days prior to dosing.
- Undergo surgery within 4 weeks prior to screening or plan to have surgery during the study.
- Hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or Human immunodeficiency virus (HIV) with positive test result.
- Donation or blood collection of > 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening.
- Receipt of another investigational product within 1 month, or 5 half-lives of the other investigational product, whichever is longer, prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research, LLC.
Los Alamitos, California, 90720
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of LY03015 in Healthy Chinese and Caucasian Adult Subjects
This is an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects. The duration of study will be around up to 42 days for each participant, including up to 14 days of screening period, baseline visit, and a 28-day safety assessment period with a 7-day/6-night stay in the clinical research unit.
Read the detailed description
A total of 24 subjects (12 Chinese, 12 Caucasians) will be enrolled. A single dose of 20 mg LY03015 will be administered orally under fasting condition. The primary objective is to characterize the pharmacokinetic (PK) profiles of LY03015 following a single oral administration in healthy Chinese and Caucasian adult subjects. The secondary objective is to evaluate the safety and tolerability of a single oral dose of LY03015.
- Conditions
- Healthy Participants
- Being tested
- LY03015 (LPM3770164 extended-release tablets)
- Keywords
- LY03015, phase 1, healthy volunteers, safety, open-label, single dose, Chinese adults, Caucasian adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03015 (LPM3770164 extended-release tablets)Drug
LY03015 (LPM3770164) is an investigational extended-release tablet administered. LY03015, a new generation dual-target drug is a selective VMAT2 inhibitor and sigma-1 receptor.
| Study group | Role | What they receive |
|---|---|---|
| Chinese healthy participants | Experimental | A single dose of 20 mg LY03015 administered on Day 1. Receives: Drug: LY03015 (LPM3770164 extended-release tablets) |
| Caucasian healthy participants | Experimental | A single dose level of 20 mg orally administered on Day 1 Receives: Drug: LY03015 (LPM3770164 extended-release tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of LY03015
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) of LY03015
Measured: 15 days
Pharmacokinetic profile of LY03015
Maximum observed concentration (Cmax) of LY03015
Measured: 15 days
Secondary outcomes (2)
Safety and tolerability of LY03015
Summary of incidence of adverse events. AE will be monitored throughout the study course
Measured: 28 days
Evaluate suicidal attempts measured by Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS measures the suicidal intensity of ideation and attempt with score of 1-5; 1 means the least severe and 5 means the most severe.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Apr 2026
- Primary completion8 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiebo Lu, Study director, Luye Pharma (USA), Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671833
- Sponsor's protocol ID
- LY03015/CT-USA-102
- Other IDs
- LY03015/CT-USA-102
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data (IPD) has not yet been determined. Data sharing policies will be established at a later stage, in accordance with institutional guidelines, ethical considerations, and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of LY03015 in Healthy Chinese and Caucasian Adult Subjects
- ClinicalTrials.gov ID
- NCT07671833
- Acronym / sponsor ID
- LY03015/CT-USA-102
- Conditions
- Healthy Participants
- Keywords
- LY03015, phase 1, healthy volunteers, safety, open-label, single dose, Chinese adults, Caucasian adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 26 Jun 2026 (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 an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects. The duration of study will be around up to 42 days for each participant, including up to 14 days of screening period, baseline visit, and a 28-day safety assessment period with a 7-day/6-night stay in the clinical research unit.
Detailed description
A total of 24 subjects (12 Chinese, 12 Caucasians) will be enrolled. A single dose of 20 mg LY03015 will be administered orally under fasting condition. The primary objective is to characterize the pharmacokinetic (PK) profiles of LY03015 following a single oral administration in healthy Chinese and Caucasian adult subjects. The secondary objective is to evaluate the safety and tolerability of a single oral dose of LY03015.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese healthy participants | Experimental | Drug: LY03015 (LPM3770164 extended-release tablets)A single dose of 20 mg LY03015 administered on Day 1. |
| Caucasian healthy participants | Experimental | Drug: LY03015 (LPM3770164 extended-release tablets)A single dose level of 20 mg orally administered on Day 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 to 45 years, inclusive.
- In good health, based on detailed medical history, clinical laboratory tests, vital signs, physical examinations, and ECGs per Investigator's judgment.
- Body mass index (BMI) is between 18.5 and 28 kg/m2, inclusive, and body weight ≥ 50 kg at screening.
- Specific ethnicity:
- All female subjects must have a negative pregnancy test result at both screening and baseline. If of childbearing potential (WOCBP) and heterosexually active, practicing or agree to practice a highly effective contraception method of birth control. Highly effective methods of birth control must be used for at least 21 days prior to study drug dosing, throughout the study, and for at least 30 days after dosing to minimize the risk of pregnancy.
Key exclusion criteria (19 listed)
- Known history of hypersensitivity to VMAT2 inhibitors; or allergic to any ingredient of the investigational drug.
- Clinically significant past medical history in the judgement of the Investigator, would interfere with the subject's ability to participate in the study.
- History of depression, akathisia, agitation, restlessness, parkinsonism, or neuroleptic malignant syndrome (NMS).
- History of suicide attempts in the past 12 months and/or evident history of risk of suicide or homicide as assessed by the Investigator.
- Known history of gastric ulceration or gastrointestinal bleeding; or inability to swallow the study drug or having gastrointestinal dysfunction that, in the Investigator's judgment, would affect drug absorption.
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 |
|---|---|---|
| LY03015 (LPM3770164 extended-release tablets)LY03015 (LPM3770164) is an investigational extended-release tablet administered. LY03015, a new generation dual-target drug is a selective VMAT2 inhibitor and sigma-1 receptor. | Drug | Caucasian healthy participants, Chinese healthy participants |
Primary outcome
Pharmacokinetic profile of LY03015
Time frame: 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) of LY03015
Pharmacokinetic profile of LY03015
Time frame: 15 days
Maximum observed concentration (Cmax) of LY03015
2 secondary outcomes
Safety and tolerability of LY03015
Time frame: 28 days
Evaluate suicidal attempts measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data (IPD) has not yet been determined. Data sharing policies will be established at a later stage, in accordance with institutional guidelines, ethical considerations, and applicable regulations.
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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. This study is not recruiting at the moment.
Jiebo Lu study director
Luye Pharma (USA), Ltd.
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 LY03015 (LPM3770164 extended-release tablets) in people with Healthy Participants, run by Luye Pharma Group Ltd. 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 2 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of LY03015 (time frame: 15 days). The study lists 2 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 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.