[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Luye Pharma Group Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":274},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,65,85,108,130,151,171,193,214,236,256],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100632685","phase-1-mass-balance-study-of-14c-lpm3770164-in-healthy-participants-100632685",false,"NCT07516899","Mass Balance Study of [14C] LPM3770164 in Healthy Participants","Inclusion Criteria:\n\n1. Healthy adult Chinese males;\n2. Age at informed consent: 18-45 years (including boundary value);\n3. Body mass index (BMI) range of 19-26 kg\u002Fm2 (including the boundary value), and body weight of not less than 50 kg;\n4. There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial;\n5. Fully understand the purpose and requirements of this study, and voluntarily sign the informed consent form;\n6. Able to communicate well with the investigators and be able to complete the trial according to the protocol.\n\nExclusion Criteria:\n\n1. Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;\n2. Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment:\n3. QTcF interval \\> 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;\n4. Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion;\n5. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;\n6. Use of any drugs that inhibit or induce hepatic drug metabolizing enzyme activity within 4 weeks prior to screening;\n7. History of any clinically significant disease or disease or condition that may affect the results of the trial;\n8. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, tachycardia, atrioventricular block, QT prolongation syndrome or a family history of QT prolongation syndrome symptoms;\n9. . Patients with dysphagia, esophageal stenosis or gastrointestinal diseases that cause clinically significant symptoms or with a history of severe vomiting and diarrhea in the week prior screening;\n10. Patients who previously underwent surgery that would affect the absorption, distribution, metabolism and excretion of drugs, or had undergone major surgery or had incomplete healing of surgical incision within 6 months prior to the screening period; or planned to undergo surgery during the study period;\n11. History of drug, food, or environmental allergy, especially to components similar to the investigational product, or a known allergic constitution;\n12. Patients with symptomatic hemorrhoids or diseases accompanied by regular\u002Fongoing hematochezia, irritable bowel syndrome, and inflammatory bowel disease;\n13. History of congenital or acquired urinary tract stenosis, prostatic hyperplasia, or abnormal bladder function;\n14. Habitual diarrhea or average bowel movement frequency less than once daily;\n15. Alcoholics or regular drinkers within 6 months before screening, that is, drinking more than 14 units of alcohol per week, or alcohol breath test results \\> 0 mg\u002F100ml at screening, or drinkers within 48 hours before the use of the test drug, or unable to abstain from alcohol during the test;\n16. The average daily smoking amount in the 3 months before screening is greater than 5 cigarettes or habitual use of nicotine-containing products, or unable to abstain during the trial;\n17. Previous history of drug abuse or drug abuse, or positive urine drug abuse screening;\n18. Excessive consumption of tea, coffee and\u002For caffeine-rich beverages, grapefruit juice and other beverages that affect liver enzyme activity per day within 3 months before screening, or inability to abstain during the trial;\n19. Those with special requirements for diet or failing to comply with the unified diet;\n20. Those who plan to have strenuous exercise during the trial;\n21. Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure;\n22. Blood loss or blood donation;\n23. Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection;\n24. Those who have participated in any clinical trial within 3 months prior to screening and have received investigational drugs or used investigational devices; or those who plan to participate in other clinical trials during this study;\n25. Those who have received vaccination within 4 weeks prior to screening or plan to receive vaccination during the trial to 1 month after the end of the trial.",true,"MALE","18 Years","45 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of \\[14C\\] LPM3770164.",[27],"Huntington Disease","NOT_YET_RECRUITING","2026-04-01",{"date":31,"type":32},"2026-04-08","ACTUAL",{"date":34,"type":21},"2026-04-30",{"date":36,"type":21},"2026-07-30",{"name":38,"class":39},"Luye Pharma Group Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100623456","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-ly03020-in-acutely-psychotic-participants-with-schizophrenia-100623456","NCT07396870","A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia","A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dosed Phase II Clinical Study to Evaluate the Efficacy and Safety of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Acutely Psychotic Adult Subjects With Schizophrenia","Inclusion Criteria:\n\n* Subjects and their guardians sign informed consent voluntarily.\n* Male or female subject aged 18 to 65 years (inclusive).\n* Subject meets DSM-5 criteria for schizophrenia and confirmed using the Mandarin for China Translation Version 7.0.2).\n* According to the investigator's assessment, subject has an acute exacerbation or relapse of schizophrenia requiring hospitalization (no longer than 2 months). Continuing hospitalization does not exceed 2 weeks for patients with acute psychotic exacerbation or relapse that require the hospitalization prior to screening.\n* Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions(P1), conceptual disorganization(P2), hallucinations(P3), and suspicion, victimization (P6) at screening and baseline.\n* Subject must have a CGI-S score ≥ 4 at screening and baseline.\n\nExclusion Criteria:\n\n* \\- Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5;\n* According to the investigator's assessment, subject has a treatment-resistant schizophrenia;\n* Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS);\n* Subject has received electroconvulsive therapy treatment within 3 months prior to screening or is expected to require ECT during the study;\n* History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) within 1 year prior to screening or suicidal ideation within 6 months prior to screening, defined as affirmative responses (\"yes\") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening\u002Fbaseline;\n* History or presence of the following treatments:\n\nWithin 1 week prior to randomization or within 5 half lives (whichever is longer), subject has been treated with short acting antipsychotic drugs or other psychoactive drugs (such as antidepressants, mood stabilizers, and antiepileptic drugs), except for anti-anxiety drugs or sedative hypnotic drugs that can be used according to the protocol; Within two treatment cycles prior to randomization, subject has used long-acting antipsychotic drugs; Within 4 weeks prior to randomization, subject has used monoamine oxidase inhibitors (MAOIs); Previously used sufficient amounts and periods of clozapine for the treatment of schizophrenia;\n\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) and the abnormality has clinical significance according to the researchers' assessment at screening\u002Fbaseline; or QTc \\>450 ms (male) \u002F QTc \\>460 ms (female) based on Fridericia's formula-corrected measurements and the abnormality has clinical significance according to the researchers' assessment at screening\u002Fbaseline;\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma;.\n* Subjects with a history of orthostatic hypotension or syncope.","ALL","65 Years",{"count":51,"type":21},160,[53],"PHASE2","This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.",[56],"Schizophrenia","2026-02-02",{"date":59,"type":32},"2026-02-09",{"date":61,"type":21},"2026-03-31",{"date":63,"type":21},"2027-12-31",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100623048","phase-1-lpm6690176-in-combination-with-chemotherapy-and-bevacizumab-in-metastatic-colorectal-cancer-patients-with-ras-mutation-100623048","NCT07391566","LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","Phase 1b\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LPM6690176 Capsules in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation","Inclusion Criteria:\n\n1. Able to provide a signed informed consent;\n2. Age ≥ 18 years and ≤ 75 years, both male and female;\n3. Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation;\n4. Prior therapies for colorectal cancer:\n\n(1 ) For phase 1b patients: who have failed or intolerable to prior first-line therapy; (2) For phase 2 patients: who have not received prior systemic therapy for metastatic colorectal cancer.\n\n5\\. At least one measurable lesion according to RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 7. Life expectancy≥ 6 months; 8. Adequate bone marrow and organ function; 9. Negative pregnancy test for women of childbearing potential. patients of childbearing potential should take effective contraceptive measures during study drug treatment and until 6 months after initiation of investigational product.\n\nExclusion Criteria:\n\n1. Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) who are suitable for immune checkpoint inhibitor therapy as assessed by the investigator;\n2. Malignant tumors other than mCRC within 5 years before signing the informed consent;\n3. Patients who did not recover from the AE of previous anti-tumor treatment to ≤ Grade 1;\n4. Patients with body cavity effusion requiring local treatment or poorly controlled effusion;\n5. Symptomatic brain metastasis, history of spinal cord compression or meningeal metastasis;\n6. Underwent other therapeutic surgery other than diagnosis, biopsy, drainage, or expected to require major surgery during the study, or had unhealed wound, ulcer or fracture.\n7. Current or previous uncontrolled concomitant non-gastrointestinal disease including, but not limited to myocardial infarction, unstable angina, coronary artery\u002Fperipheral artery bypass grafting, heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, serious arrhythmia, current uncontrolled hypertension, previous history of hypertensive crisis or hypertensive brain disease, tumor invasion into major blood vessels, interstitial lung disease, interstitial pneumonia, pulmonary interstitial fibrosis, reversible posterior leukoencephalopathy syndrome (RPLS), etc.;\n8. Current or past presence of the gastrointestinal abnormalities, including but not limited to active peptic ulcer, clinically significant gastrointestinal abnormalities prior to informed consent, active colitis, long-term anticoagulant therapy, antiplatelet therapy, etc.;\n9. Current or past significant risk of bleeding;\n10. Use of prohibited medication or therapy within the specified time;\n11. History of drug abuse or alcoholism;\n12. Known hypersensitivity to any component of any investigational product;\n13. Pregnant and lactating women;\n14. Other conditions that may increase the risk of the study or interfere with study results, in the judgment of the investigator.","75 Years",{"count":74,"type":21},99,[24,53],"This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and Bevacizumab in patients with RAS mutant metastatic colorectal cancer (mCRC), to observe the dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D); Phase 2 is planned to preliminarily evaluate the efficacy of LPM6690176 capsule in combination with chemotherapy + Bev vs. chemotherapy + Bev in patients with previously untreated, RAS mutant mCRC.",[78],"Metastatic Colorectal Cancer (mCRC)",{"date":80,"type":32},"2026-02-06",{"date":61,"type":21},{"date":83,"type":21},"2028-12-31",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":40},"100610674","phase-1-a-phase-1-mad-study-to-evaluate-the-safety-and-tolerability-of-ly03020-100610674","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.","60 Years",{"count":94,"type":21},40,[24],"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.",[56,98],"Alzheimer's Disease Psychosis","RECRUITING","2025-11-18",{"date":102,"type":32},"2025-11-19",{"date":104,"type":32},"2025-08-20",{"date":106,"type":21},"2026-02-28",{"name":38,"class":39},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":40},"100591421","phase-1-a-phase-1-mad-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-ly03017-100591421","NCT06980207","A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.","Inclusion Criteria:\n\n* Subject who voluntarily participate and sign the informed consent form.\n* Healthy male\u002Ffemale volunteers aged ≥18 and ≤ 45 years.\n* Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and \\\u003C 28.0 kg\u002Fm2.\n* Able to comply with the lifestyle restrictions.\n\nExclusion Criteria:\n\n* Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.\n* Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.\n* Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.\n* Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as Pulse \\\u003C 55 beats\u002Fmin or \\> 100 beats\u002Fmin, Systolic blood pressure \\\u003C 90 mmHg or ≥140 mmHg, Diastolic blood pressure \\\u003C 60 mmHg or ≥90 mmHg.\n\nQT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .\n\n* Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.\n* Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.\n* Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).\n* Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.\n* Subject has a history of substance abuse within 1 year or a positive urine drug screen.\n* Subject who has daily smoking of ≥ 5 cigarettes within 3 months.\n* Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.\n* Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods\u002Fdrinks) within 48 hours prior to dosing and\u002For subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.\n* Subject who has participated in other clinical trials within 3 months before administration.\n* Subject has used blood products or being blood donor or blood loss within 3 months.\n* Pregnant, lactating women, or positive pregnancy test.\n* Subject who refusal to contraception, or plan to donate sperm or ovums.\n* Subject who has a history of needle or blood faintness.\n* Subject directly involved in this clinical trial.\n* Poor compliance or other conditions which would make participation in the study unsuitable.",{"count":94,"type":21},[24],"This is a phase 1，randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects",[119,120,121],"Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis","Hallucinations and Delusions Associated With Parkinson Disease Psychosis","Negative Symptoms of Schizophrenia","2025-05-12",{"date":124,"type":32},"2025-05-20",{"date":126,"type":21},"2025-05",{"date":128,"type":21},"2025-10",{"name":38,"class":39},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":40},"100577107","phase-1-effect-of-food-and-age-on-the-pharmacokinetics-of-ly03017-100577107","NCT06793995","Effect of Food and Age on the Pharmacokinetics of LY03017","A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers","Inclusion Criteria:\n\n* Subject who voluntarily participate and sign the informed consent form.\n* Part A：Age ≥18 and ≤ 45 years, male and female.\n* Part B：Age ≥65 years, male and female.\n* Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and \\\u003C 28.0 kg\u002Fm2.\n* Able to comply with the lifestyle restrictions.\n\nExclusion Criteria:\n\n* Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.\n* Part A：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.\n* Part B：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.\n* Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.\n* Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as\n\n  1. Pulse \\\u003C 55 beats\u002Fmin or \\> 100 beats\u002Fmin,\n  2. Systolic blood pressure \\\u003C 90 mmHg or ≥140 mmHg, Diastolic blood pressure \\\u003C 60 mmHg or ≥90 mmHg,\n  3. QT interval (QTc) ≥450 ms.\n  4. Part B：aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin \\> 1.5 × upper limit normal (ULN), or estimated glomerular filtration rate（eGFR） \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* Part A：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.\n* Part B：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing, with the exception of concomitant drugs for the well-controlled, chronic and stable medical conditions.\n* Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.\n* Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).\n* Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.\n* Subject has a history of substance abuse within 1 year or a positive urine drug screen.\n* Subject who has daily smoking of ≥ 5 cigarettes within 3 months.\n* Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.\n* Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods\u002Fdrinks) within 48 hours prior to dosing and\u002For subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.\n* Subject who has participated in other clinical trials within 3 months before administration.\n* Subject has used blood products or being blood donor or blood loss within 3 months.\n* Pregnant, lactating women, or positive pregnancy test.\n* Subject who refusal to contraception, or plan to donate sperm or ovums.\n* Subject who has a history of needle or blood faintness.\n* Subject directly involved in this clinical trial.\n* Poor compliance or other conditions which would make participation in the study unsuitable.",{"count":138,"type":21},26,[24],"This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.",[98,142,121],"Parkinson Disease Psychosis","2025-01-20",{"date":145,"type":32},"2025-01-27",{"date":147,"type":21},"2025-02",{"date":149,"type":21},"2025-10-31",{"name":38,"class":39},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":40},"100572330","phase-1-safety-and-efficacy-of-lpm3770164-sustained-release-tablets-in-patients-with-tardive-dyskinesia-100572330","NCT06731868","Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia","Inclusion Criteria:\n\n1. Subject who voluntarily participate in and sign the informed consent form;\n2. Male or female subjects aged ≥ 18 years and \\\u003C 65 years;\n3. Body mass index (BMI) 18.5 \\~ 38.0 kg\u002Fm2 (including boundary value);\n4. Subjects with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical history, and stable for at least 1 month;\n5. Subjects who have been diagnosed with medication-induced TD, and whose symptoms have lasted for at least 3 months according to the DSM-5; and TD is assessed as moderate or severe (AIMS Item 8 score ≥3);\n6. Medications for schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders and extrapyramidal reactions should be kept dose stable for at least 1 month (benzodiazepines should stable at least 14 days, Long-acting injection should stable for at least 3 months);\n7. Females of childbearing potential have a negative pregnancy test. Male and female patients of childbearing potential and their spouses\u002Fpartners agree to not plan to become pregnant (including the plan for sperm and egg donation) and to use effective contraceptive measures throughout the study and for at least 1 month after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Has comorbid abnormal involuntary movement(s) that is more prominent than TD as judged by the investigator;\n2. Has Simpson-Angus Scale (SAS) score≥ 3 on two or more items other than items 8 and 10;\n3. Currently in the acute phase of mental disorder or severe psychiatric symptoms, unable to cooperate with the treatment and assessment, as judged by the investigator;\n4. Has a history of suicide attempt or Question 4 or Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as \"Yes\" within the past 6 months;\n5. Has a history of neuroleptic-related malignant syndrome;\n6. Has diagnosed with malignant tumor within 3 years before randomization;\n7. Has a history of long QT syndrome or tachyarrhythmia within 3 years before randomization;\n8. Electrocardiogram QTcF \\> 450 ms, or other clinically significant ECG findings in the opinion of the investigator;\n9. Patients with significant abnormal liver and kidney function indicators, meeting any of the following criteria: serum creatinine \\> 1.5 × upper limit of normal (ULN); serum alanine transaminase (ALT) or aspartate transaminase (AST) \\> 2.5 × ULN; total bilirubin \\> 1.5 × ULN;\n10. Has active, severe and unstable cerebrovascular, liver, kidney, endocrine, cardiovascular, gastrointestinal, respiratory, or metabolic disorders within 30 days prior to screening, in the judgment of the investigator, would interfere with the patient's ability to participate in the trial;\n11. Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as but not limited to history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding;\n12. Has a known history of allergy to any component of the investigational product or similar drugs, or allergic constitution;\n13. Has a positive human immunodeficiency virus antibody (HIV-Ab) and syphilis;\n14. Has a positive urine drug screen;\n15. Patients diagnosed with substance-related and addictive disorders (except tobacco- or caffeine-related disorders) within 6 months prior to the screening visit;\n16. Has participated in any clinical trials of drugs (excluding vitamins and minerals) within 3 months prior to the screening visit;\n17. Patients who previously received deep brain stimulation (DBS), or received electroconvulsive therapy (ECT) or other physical therapy within 1 month prior to the screening visit;\n18. Patients who use of strong inducers or inhibitors of CYP3A4 within 14 days or 5 half-lives, whichever is longer, prior to randomization;\n19. Known history of a nonresponder to tetrabenazine, deutetrabenazinen, or valbenazine for the treatment of TD;\n20. Patients who have been injected with botulinum toxin in the past 3 months;\n21. Patients who have used the prohibited drugs in the past 1 month;\n22. Nursing mothers;\n23. For patients with schizophrenia and schizoaffective disorder, has a total PANSS score \\> 80, and\u002For a total CDSS score \\> 10;\n24. For patients with bipolar and related disorders or depressive disorders, has a history of rapid cycling, or a total MADRS score \\> 22, or a total YMRS score \\> 12;\n25. Other conditions judged by the investigator as unsuitable for participating in the trial.","64 Years",{"count":160,"type":21},120,[24,53],"This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.",[164],"Tardive Dyskinesia (TD)",{"date":166,"type":32},"2025-01-22",{"date":168,"type":32},"2025-01-14",{"date":149,"type":21},{"name":38,"class":39},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":40},"100554204","phase-3-lurbinectedin-or-in-combination-with-irinotecan-versus-topotecan-in-patients-with-relapsed-sclc-100554204","NCT06496048","Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC","A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n1. Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.\n2. Men or women ≥18 years of age.\n3. Histologically or cytologically confirmed SCLC.\n4. Life expectancy ≥12 weeks.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).\n6. One prior line of etoposide + platinum chemotherapy with\u002Fwithout anti-PD-1 or anti-PD-L1 (Note: at least 70% of the patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)\n7. Chemotherapy-free interval (CTFI, i.e., the time from the last dose of first-line platinum-based chemotherapy to the occurrence of disease progression) ≥30 days.\n8. At least one measurable lesion (in accordance with RECIST 1.1 criteria).\n9. Adequate organ function as defined below:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 109\u002FL, and platelet count ≥ 100 × 109\u002FL.\n   2. Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN.\n   3. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN.\n   4. Albumin ≥ 3.0 g\u002FdL.\n   5. Calculated creatinine clearance (CrCL) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula, as detailed in Appendix IV).\n10. ≥ 3 weeks since the last anti-tumor therapy and recovery of adverse events (AEs) related to prior anti-tumor therapy to Grade ≤ 1, as judged by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) (Except for anemia; and recovery to Grade ≤ 2 for sensory neuropathy, asthenia and alopecia).\n11. Female patients of childbearing potential must have a negative blood or urine pregnancy test prior to enrollment, and must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 7 months after the last dose. Male patients with a female partner of childbearing potential must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 4 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.\n2. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).\n3. Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).\n4. Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).\n5. Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and\u002For therapeutic) at other sites within 2 weeks prior to randomization.\n6. Patients with limited-stage disease who plan to receive local or regional treatment (including PCI, thoracic radiotherapy, or both) during the study (Note: patients with extensive-stage disease may receive radiotherapy during the study if they meet the requirements as described in Section 5.8.1).\n7. Patients who, at the screening visit, are about to receive radiotherapy, such as for painful bone metastasis and\u002For risk of spinal cord compression. Patients who have a history of bone marrow and\u002For stem cell transplantation and allogeneic transplantation.\n8. Having received a live vaccine or attenuated live vaccine within 30 days before the first dose of the investigation medicinal product (inactivated vaccines are allowed).\n9. Concomitant diseases:\n\n   1. Having unstable angina pectoris, myocardial infarction, congestive heart failure (CHF) of New York Heart Association (NYHA) class II or above, or clinically significant heart valve diseases within one year prior to screening.\n   2. Having symptomatic arrhythmia, or arrhythmia with unstable control and requiring continuous treatment at screening.\n   3. Patients requiring continuous oxygen inhalation within 2 weeks prior to randomization.\n   4. Patients with confirmed or suspected diffuse interstitial lung disease or pulmonary fibrosis.\n   5. Patients who have rapidly increasing pleural or pericardial effusion with significant symptoms, and\u002For need prompt local therapy within 7 days, at screening.\n   6. Hepatic cirrhosis with the Child-Pugh score (see Appendix II for the scoring criteria) of B or C.\n   7. Patients with Gilbert's disease.\n   8. Patients with persistent non-neoplastic chronic liver disease (of any etiology) requiring treatment, including those with positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer ≥ 500 IU\u002FmL, those with positive hepatitis C antibody and hepatitis C virus ribonucleic acid (HCV-RNA) titer ≥ 100 IU\u002FmL, and those having received hepatitis-related antiviral therapy within 6 months prior to the first dose of the investigational medicinal product.\n   9. Chronic inflammatory bowel disease or intestinal obstruction (including intestinal pseudo-obstruction, incomplete intestinal obstruction, enteroparalysis, etc.) in the past or at screening.\n   10. Patients with uncontrolled active infection who have received systemic intravenous anti-infective therapy within 1 week prior to randomization.\n   11. Having severe and uncured wounds, ulcers, fractures, and external drainage disposal at screening.\n   12. Patients with confirmed or suspected invasive fungal infection within 12 weeks prior to randomization who need systemic treatment.\n   13. Positive for human immunodeficiency virus (HIV) antibody at screening.\n   14. Patients with prior history of malignant tumors other than SCLC, except those who have undergone radical resection more than 3 years prior to randomization and have a sustained response after treatment (e.g., cervical carcinoma in situ, basal or squamous cell skin cancer, transitional cell bladder cancer in situ, etc.).\n   15. Any other major disease that, at the discretion of the investigator, can significantly increase the risk associated with participation in this study.\n10. Having a history of allergy or hypersensitivity to any of the investigational medicinal products or any of their excipients.\n11. Drug abuse, drug addiction or alcohol abuse (alcohol abuse is defined as drinking more than 14 units of alcohol per week within 3 months prior to signing the informed consent \\[1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine\\]).\n12. Pregnant or lactating women and patients of childbearing age who cannot use highly effective contraceptive methods (regardless of gender) (see Inclusion Criterion #11).\n13. Those who cannot fully comply with the treatment plan or comply with the study protocol, as judged by the investigator.",{"count":179,"type":21},180,[181],"PHASE3","Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.",[184],"Relapsed Small Cell Lung Cancer","2024-12-09",{"date":187,"type":32},"2024-12-12",{"date":189,"type":32},"2024-09-14",{"date":191,"type":21},"2028-06-30",{"name":38,"class":39},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":40},"100552001","phase-2-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-lpm3480392-injection-for-moderate-to-severe-pain-after-orthopedic-surgery-100552001","NCT06467409","Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery","A Multicenter, Randomized, Double-blind, Placebo, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form (ICF) and comply with the trial procedures before starting the trial-related activities;\n2. Over 18 years old , male or female;\n3. Body mass index (BMI) 18-28 kg\u002Fm2 (including the boundary value)；\n4. Subjects who plan to undergo unilateral total knee replacement or unilateral knee ligament reconstruction under general anesthesia; ;\n5. American Society of Anesthesiologists(ASA )grade I \\~ II;\n6. Female subjects with a negative pregnancy test at Screening. Male and female subjects agree to take effective contraceptive measures throughout the study and for at least 1 month after medication;\n7. the numerical rating scale(NRS) score at rest was ≥ 4 points within 4 hours after surgery.\n\nExclusion Criteria:\n\n1. Known history of allergy to any component of the investigational product, or allergy or contraindication to the anesthetic\u002Fanalgesic drugs used in the study;\n2. Had any of the following conditions or medical history:\n\n   1. History of stroke, cognitive dysfunction, or epilepsy (excluding convulsions caused by previous febrile convulsions in children);\n   2. History of difficult airway, such as obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory diseases or other serious respiratory diseases;\n   3. Subjects with a history of myocardial infarction, angina pectoris, severe arrhythmia of degree II or above atrioventricular block, or New York Heart Association(NYHA) Class II or above within 6 months prior to screening;\n   4. History of vestibular dysfunction or motion sickness;\n   5. Have a history of diabetes and glycosylated hemoglobin ≥ 9% during the screening period;\n   6. Esophagitis;\n   7. Paralytic gastrointestinal obstruction;\n   8. The presence of other acute and chronic pain conditions preoperatively or in combination with other bodily pain conditions that confound the evaluation of postoperative pain.\n3. Medications affecting postoperative analgesia before randomization ：\n\n   a) Opioid analgesics taken continuously for more than 10 days for any reason within 3 months prior to randomization, or taking drugs that involving analgesia prior to randomization and The time from last drug use to randomization is less than 5 half-lives( in accord with label ; unless t1\u002F2 is unkown，execute according to 48h ) ,including but not limited to: ketamine, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, parecoxib sodium, etc.), alpha adrenoceptor agonists (dexmedetomidine hydrochloride, clonidine, etc.), glucocorticoids (dexamethasone hydrochloride, hydrocortisone, methylprednisolone, etc., except for topical or topical use of glucocorticoids), antiepileptic drugs (carbamazepine, sodium valproate, etc.), sedative drugs (diazepam, estazolam, midazolam, alprazolam, barbiturate, phenobarbital and chloral hydrate, etc.); b. Use of Chinese herbal medicine or Chinese patent medicine which has the function of analgesia, sedation, antiemetic within 48h prior to randomization.\n4. Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure 60 mmHg or greater in screening phase;\n5. oxygen saturation by pulse oximetry(SpO2) \\\u003C 92% at screening ;\n6. Corrected QT interval(QTc )\\> 450 ms for males and \\> 460 m for females at screening ;\n7. Patients with abnormal liver and kidney function during screening period:alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 1.5 times of normal value, total bilirubin higher than the upper limit of normal value, serum creatinine (Cr) \\> 1.5 times of the upper limit of normal value during screening period;\n8. Subjects with coagulation abnormalities (PT prolonged more than 3 seconds above the upper limit of normal and\u002For activated partial thromboplastin time(APTT) prolonged more than 10 seconds above the upper limit of normal) during the screening period; and the investigator confirmed that the abnormalities were clinically significant;\n9. History of drug abuse or drug abuse before screening;\n10. Positive result in screening of drugs of abuse via urinalysis;\n11. Lactating mothers;\n12. hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody positive ;\n13. Participation in any medication (excluding vitamins and minerals) within 3 months prior to informed consent Quality) Clinical trial personnel, except for those not using investigational drugs;\n14. subjects who are judged by the investigator to be not suitable for this clinical trial, including but not limited to the presence of conditions that may confound the interpretation of efficacy, safety, or tolerability data in this study.",{"count":201,"type":21},150,[53],"A randomized, double-blind, placebo\u002Fpositive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery",[205],"Pain, Postoperative","2024-06-20",{"date":208,"type":32},"2024-06-21",{"date":210,"type":32},"2024-01-26",{"date":212,"type":21},"2025-01",{"name":38,"class":39},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100548860","phase-4-to-evaluate-the-long-term-efficacy-and-safety-of-toludevenlafaxine-hydrochloride-sustained-release-tablets-100548860","NCT06426485","To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets","A Multicenter, Randomized Withdrawal, Double-blind, Parallel, Placebo-controlled Design Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets","Inclusion Criteria:\n\n1. The subject voluntarily signs the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures;\n2. Aged 18 years and above, male or female;\n3. Outpatients with the main diagnosis of depression meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for recurrent episodes (without psychotic features) (F33.1\u002FF33.2);\n4. MADRS total score ≥ 26 at baseline of screening and open treatment phase.\n\nExclusion Criteria:\n\n1. Patients who meet the criteria of treatment-resistant depression, that is, patients who have failed to respond to at least two antidepressants with different mechanisms of action in the case of adequate treatment (at least 8 weeks of treatment at the maximum recommended therapeutic dose);\n2. Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (allergic to two or more drugs or food) and the investigator considers it inappropriate to participate in the trial;\n3. Significant suicide attempt (defined as a score of ≥ 4 on item 10 of the MADRS scale) or suicidal behavior in the past 6 months on the Columbia-Suicide Severity Rating Scale (C-SSRS) (\"actual attempt\",\"interrupted attempt\", and\"abandoned attempt\"with any outcome of\"yes\");\n4. Other diseases meeting DSM-5 diagnostic criteria, including organic mental disorders, substance-related and addictive disorders (except nicotine or caffeine), schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance\u002Fdrug-induced depressive disorders, depressive disorders due to other physical\u002Fmental diseases, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders;\n5. Previous history of increased intraocular pressure or closed glaucoma;\n6. Patients with poorly controlled hypertension \\[screening or baseline sitting systolic blood pressure (SBP) ≥ 160 mmHg or sitting diastolic blood pressure (DBP) ≥ 100 mmHg\\];\n7. Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, or creatinine 1.5 times higher than the upper limit of normal at screening;\n8. Female patients who are pregnant or have a positive pregnancy test result, or male and female subjects of childbearing potential do not agree to use effective contraception throughout the study and for at least 1 month after discontinuation;\n9. Patients who received electroconvulsive therapy (ECT) within 3 months before screening or currently require ECT according to the investigator's judgment;\n10. Patients who have received or are receiving systemic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before screening or currently need systemic psychotherapy according to the investigator's judgment;\n11. Patients who received physical therapy such as transcranial magnetic stimulation (TMS), deep brain stimulation, vagus nerve stimulation and transcranial electrical stimulation within 3 months before screening;\n12. Patients who received phototherapy within 2 weeks before screening;\n13. Patients who have stopped antidepressant drugs for less than 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors (MAOIs) and 1 month for fluoxetine) before enrollment;\n14. Those who have participated in other clinical trials within 1 month before screening (excluding those who are not eligible after screening and not enrolled);\n15. Currently suffering from acute or severe unstable physical illness, or other conditions that the investigator judges the subject is not suitable for the study.",{"count":222,"type":21},736,[224],"PHASE4","This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.",[227],"Major Depressive Disorder","2024-05-17",{"date":230,"type":32},"2024-05-23",{"date":232,"type":21},"2024-05-30",{"date":234,"type":21},"2027-06-30",{"name":38,"class":39},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":72,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":40},"100534570","phase-1-first-in-human-study-of-lpm6690176-in-patients-with-advanced-solid-tumors-100534570","NCT06240546","First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.","A Phase I, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LPM6690176 Capsules in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Able to provide a signed informed consent;\n2. Age 18 \\~ 75 years, male or female;\n3. Patients with histologically or cytologically confirmed advanced or metastatic unresectable solid tumors, who failed or intolerant to standard anti-tumor therapy or lack of standard therapy;\n4. According to RECIST 1.1 criteria,\n\n   * Dose escalation phase: patients with at least one non-measurable lesion;\n   * Dose expansion phase: patients with at least one measurable lesion;\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;\n6. Life expectancy≥ 3 months;\n7. Adequate bone marrow, liver, kidney, metabolism and coagulation function (blood transfusion, colony stimulating factors, albumin, and blood products are not allowed to use within 14 days before enrollment);\n8. Negative pregnancy test within 7 days before first dose of study drug treatment in women of childbearing age. Female patients with childbearing potential were to use effective contraception during and for 6 months after the first dose of study drug treatment. Male patients (female partners with childbearing potential) should take effective contraceptive measures during study drug treatment and until 4 months after last dose of study drug administration.\n\nExclusion Criteria:\n\n1. Patients who have not recovered from AEs caused by previous anti-tumor therapy to ≤ Grade 1 (assessed according to NCI-CTCAE 5.0 criteria, excluding alopecia and ≤ Grade 2 peripheral sensory neuropathy);\n2. Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before signed informed consent decided by the investigator;\n3. Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis;\n4. Concomitant Diseases:\n\n   * Any of the following diseases within 6 months before the first dose of study treatment: myocardial infarction, unstable angina, coronary artery\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, and serious arrhythmia requiring treatment;\n   * Patients who require long-term anticoagulant therapy or anti-platelet therapy or require long-term use of non-steroidal anti-inflammatory drugs;\n   * Patients with uncontrolled hypertension, hypertensive crisis or history of hypertensive encephalopathy;\n   * Patients with increased risk of gastrointestinal ulcer or gastrointestinal bleeding tendency or gastrointestinal perforation tendency;\n   * Patients with known active colitis within 8 weeks prior to screening, or diarrhea ≥4 times in 24 hours;\n   * Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks before the first dose of study drug treatment;\n   * HBsAg (+) and HBV DNA≥ 1×103 or HCV (+) or HIV (+);\n   * Patients who have undergone major surgical procedures 4 weeks before the first dose of study drug treatment, or have severe injury, or requiring elective major surgery during the study, or have unhealed wounds, ulcers or fractures;\n   * Exclusion criterion specific to dose expansion phase: patients who have any malignancy within 5 years before the first dose of study treatment except for the specific cancer under investigation in this study (cured carcinoma in situ of the cervix, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of breast ductal are eligible).\n5. Prior Medications:\n\n   * Patients who received anti-tumor therapy within 4 weeks before the first dose of study drug treatment;\n   * Received LPM6690176 capsules or other PLK-1 inhibitors therapy before enrollment;\n   * Received live attenuated vaccination within 4 weeks before signed informed consent;\n   * Use of strong inducers or strong inhibitors of CYP3A4 within 2 weeks or 5 half-lives of the medication before the first dose of study drug treatment;\n   * Use of medications mainly metabolized by CYP2B6 within 2 weeks or 5 half-lives (which takes longer time) of the medication before the first dose of study drug treatment;\n6. Patients who may receive other systemic anti-tumor therapy or local radical therapy of target lesions\u002Fnon-target lesions during the study;\n7. History of drug abuse, drug addiction, or alcoholism;\n8. Known hypersensitivity to any component of the study drug;\n9. Patients who participated in other clinical trials and received treatment within 1 month;\n10. Pregnant or lactating women;\n11. Other conditions that may elevate the risk of the patient or interfere the study results decided by the investigator.",{"count":244,"type":21},102,[24],"This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176 capsules in patients with advanced solid tumors.",[248],"Advanced Solid Tumor","2024-03-12",{"date":251,"type":32},"2024-03-15",{"date":249,"type":32},{"date":254,"type":21},"2027-02",{"name":38,"class":39},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":40},"100525984","phase-3-study-of-ly01610-in-patients-with-recurrent-small-cell-lung-cancer-100525984","NCT06128837","Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer","A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female;\n2. Patients with histologically and\u002For cytologically confirmed small cell lung cancer;\n3. Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery;\n4. At least one evaluable lesion (according to RECIST 1.1 criteria);\n5. Expected survival time ≥ 3 months;\n6. Eastern Cooperative Oncology Group (ECOG) score \\\u003C 2;\n7. Patients who received no liver metastasis; or the number of liver metastases was ≤ 3 and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longest diameter of a single lesion was \\> 1.5 cm, the imaging was stable for at least 3 weeks after local treatment control;\n8. Patients with brain metastasis at baseline should meet all the following conditions: lesions not involving the brainstem, the number of brain metastases ≤ 2 (but patients with only intracranial target lesions should be excluded), imaging stability for at least 3 weeks after local treatment control, and no application of dehydration drugs and hormones before screening,Without any symptoms of brain metastasis;\n9. Organ function meeting the following criteria at screening: a.Blood routine: neutrophil (ANC) ≥ 1.5 × 109\u002FL, platelet (PLT) ≥ 100 × 109\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g\u002FL; c.Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL\u002Fmin; d.Coagulation function: Prothrombin time - international normalized ratio (PT-INR) \\\u003C 1.5;\n10. Has fully understood and voluntarily signed a written informed consent form for this study and is able to comply with the requirements and restrictions listed in the informed consent form;\n11. Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to use reliable contraceptive measures during the study and within 6 months after the infusion of study drug.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of compound small cell lung cancer;\n2. Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;\n3. Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy\u002Fsurgery\u002Fendoscopic therapy\u002Fintervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and\u002For pericardial effusion with local treatment and unstable control;\n4. Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;\n5. Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,\n6. Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis; Patients with severe gastrointestinal diseases or gastrointestinal disorders (such as gastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immune enteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis, diarrhea \\> grade 1, other gastrointestinal diseases that may affect the tolerance of chemotherapy) at screening;\n7. Patients with the following cardiovascular and cerebrovascular diseases or history:\n\n   1. patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis or hypertensive encephalopathy;\n   2. patients with unstable severe arrhythmia;\n   3. patients with the following cardiovascular and cerebrovascular diseases within 6 months: myocardial infarction, unstable angina, coronary revascularization\u002Fangioplasty, coronary artery bypass grafting, coronary artery stenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history, active cerebral infarction, active cerebral hemorrhage;\n8. Patients with any of the following conditions:\n\n   1. positive hepatitis B virus surface antigen (HBsAg) test,And peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU\u002FmL;\n   2. hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleic acid (HCV-RNA) detection ≥ 100 IU\u002FmL;\n   3. human immunodeficiency virus antibody (HIV-Ab) detection positive;\n9. Other malignancies within 5 years before screening (except cured stage IB or lower cervical cancer, non-invasive basal cell, scale-cell skin cancer or resectable carcinoma in situ);\n10. Patients with primary diseases of other important organs (such as nervous system, cardiovascular and cerebrovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system diseases) and the researchers believe that it is not suitable for participants, or for other reasons the researchers believe that it is not suitable for participants;\n11. Previous treatment with irinotecan or irinotecan modified, topotecan or other topoisomerase I inhibitors;\n12. Known hypersensitivity to irinotecan hydrochloride liposomes or its excipients, structurally similar compounds (such as camptothecin compounds), other liposomal drugs, and topotecan;\n13. Those who have been vaccinated with live vaccine or live attenuated vaccine before screening;\n14. Patients who have received systemic anti-tumor therapy in 4 weeks before randomization;\n15. Patients who have applied other clinical trial drugs\u002Fdevices before randomization;\n16. Patients who have used strong inducers or strong inhibitors of CYP3A4 and strong inhibitors of UGT1A1 before randomization;\n17. Adverse reactions caused by previous anti-tumor treatment are not recovered to grade 1 or lower (except alopecia and peripheral neuropathy);\n18. History of drug abuse, drug abuse and\u002For alcoholism;\n19. Pregnant or lactating women;\n20. Other conditions (including but not limited to unstable nervous system diseases and mental disorders) that are considered unsuitable for inclusion in this trial by the investigator.",{"count":264,"type":21},686,[181],"This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)",[184],{"date":251,"type":32},{"date":270,"type":32},"2024-03-03",{"date":272,"type":21},"2028-10",{"name":38,"class":39},""]