New drug LY03015 tested for safety in healthy people
NCT ID NCT07671833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested the safety and how the body processes a new drug called LY03015 in 24 healthy adults from Chinese and Caucasian backgrounds. Participants took a single dose and were monitored for about a month. The study is complete and focused on gathering basic safety information, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY03015 (extended-release tablet)
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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May 2026
- Lead sponsor
-
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
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
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: * 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: 1. 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. 2. 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. Exclusion Criteria: * 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. * 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: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times the upper limit of normal (ULN); 2. Serum creatinine \> ULN; 3. Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m²; 4. 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Collaborative Neuroscience Research, LLC.
Los Alamitos, California, 90720, United States
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