[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610674":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Luye Pharma Group Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LY03020","EXPERIMENTAL","Subjects will take LY03020 from Day 1 to Day 7",[13],"Drug: LY03020",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subjects will take Placebo from Day 1 to Day 7",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","administered orally",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Yufeng Wang","CONTACT","86+18665029373","wangyufeng@luye.com",[35],{"facility":36,"status":37,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing AnDing Hospital Capital Medical University","RECRUITING","Beijing","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":25,"email":51},"Anning Li","86+13141209427","anning.li@hotmail.com",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100610674","phase-1-a-phase-1-mad-study-to-evaluate-the-safety-and-tolerability-of-ly03020-100610674",false,"NCT07230652","A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020","A Randomized, Double-Blind, Placebo-Controlled, Dose- Ascending Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Chinese Adult Healthy Subjects and\u002For Subjects With Stable Schizophrenia","Inclusion Criteria:\n\nHealthy Subjects\n\n* Subjects sign informed consent voluntarily.\n* Male or female aged 18 to 45 years.\n* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg\u002Fm2 Subjects with Stable Schizophrenia\n* Subjects themselves and \u002F or their guardians sign informed consent voluntarily.\n* Male or female aged 18 to 60 years.\n* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg\u002Fm2.\n* Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.\n\nExclusion Criteria:\n\nHealthy Subjects\n\n* Subjects have any clinically significant medical condition or chronic disease.\n* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with a history of orthostatic hypotension or syncope.\n* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.\n* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.\n* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.\n* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation\n* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody. Subjects with Stable Schizophrenia\n* According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.\n* Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;\n* History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses (\"yes\") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening\u002Fbaseline;\n* Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements\u002Ftraditional Chinese herbal products within 7 days prior to first dosing.\n* Glycated hemoglobin (HbA1c) ≥7% at screening\u002Fbaseline.\n* Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate \\\u003C50 beats per minute (bpm) at screening\u002Fbaseline; or QTc \\>450 ms (male) \u002F QTc \\>460 ms (female) based on Fridericia's formula-corrected measurements at screening\u002Fbaseline.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with a history of orthostatic hypotension or syncope.",true,"ALL","18 Years","60 Years",{"count":66,"type":67},40,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and\u002For subjects with stable schizophrenia.",[73,74],"Schizophrenia","Alzheimer's Disease Psychosis","2025-11-18",{"date":77,"type":78},"2025-11-19","ACTUAL",{"date":80,"type":78},"2025-08-20",{"date":82,"type":67},"2026-02-28",{"name":5,"class":6},1]