[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chengdu Kanghong Pharmaceutical Group Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,57,80,101,123,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"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":4},"100649980","phase-3-a-study-of-kh607-as-monotherpy-in-adults-participants-with-major-depressive-disorder-100649980",false,"NCT07741240","A Study of KH607 as Monotherpy in Adults Participants With Major Depressive Disorder","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder","Inclusion Criteria:\n\n1. Age: 18 to 65 years old (inclusive), Male or female.\n2. Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2\u002F296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month\n3. Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).\n4. Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥24, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline\n5. Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg\u002Fm²\n6. Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.\n7. Participant is willing to stop other antidepressants, antipsychotics, mood stabilizers, sedatives and hypnotics during the trial.\n8. Fully understand the procedures and sigh the informed consent.\n\n   Only for long-term studys:\n9. Participants who complete the short-term study (Visit 8 completion), have a ≥50% reduction from short-term study baseline in HAM-D17 total score at Visit 8, and volunteer to enter the long-term study.\n\nKey Exclusion Criteria:\n\n1. Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.\n2. A reduction of ≥25% in HAM-D17 total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).\n3. Participants with clinically significant risk of suicide or self-harm, defined as any of the following:\n\n   1. A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;\n   2. An answer of \"Yes\" to Question 4 (active suicidal ideation with intent without specific plan) or Question 5 (active suicidal ideation with specific plan and intent) of the C-SSRS within the past 6 months at screening, or a suicide-related behavior within the past 6 months (any \"Yes\" response for Actual Attempt, Interrupted Attempt, or Aborted Attempt).\n4. Participants meeting any of the following depressive disorder diagnoses:\n\n   1. Poor response to adequate dose and adequate duration (at least 6 weeks) of two or more antidepressants with distinct pharmacological mechanisms during a prior depressive episode (based on Investigator interview, to be adjudicated and documented by the Investigator);\n   2. Depressive disorder secondary to other psychiatric disorders or somatic diseases (e.g., depression induced by hypothyroidism);\n   3. Substance\u002Fmedication-induced depressive disorder.\n5. Participants receiving structured psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other therapies from screening through baseline, who require continuation of such therapies during the study.\n6. Receipt of depression-related neuromodulation therapies within 1 month prior to enrollment, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS).\n7. Prior use of atypical antipsychotics or mood stabilizers during the current depressive episode (e.g., olanzapine, risperidone, quetiapine, aripiprazole, brexpiprazole, ziprasidone, cariprazine, valproate, lithium carbonate).\n8. Use of any strong CYP3A4 inhibitor or inducer within 14 days (or 5 half-lives, whichever is longer) prior to enrollment.\n9. Abnormal hepatic or renal function prior to enrollment: liver function abnormalities (ALT or AST \\>2×ULN), renal function abnormalities (Cr \\>1.5×ULN), or other conditions deemed inappropriate for enrollment by the Investigator.\n10. Positive test results at screening for active hepatitis B (HBV-DNA ≥1000 copies\u002FmL or 200 IU\u002FmL), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody.\n11. 12-lead electrocardiogram (ECG) showing second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF \\>450 ms (male) \u002F 460 ms (female) prior to enrollment; or other conditions unsuitable for participation as judged by the Investigator (e.g., clinically significant tachyarrhythmia requiring intervention).\n12. Severe hypothyroidism (TSH ≥10.0 mIU\u002FL).\n13. Participants with current obstructive sleep apnea and\u002For narcolepsy.\n14. Known or suspected history of hypersensitivity to the investigational product or its excipients, or participants with multiple allergies (defined as allergies to at least 2 different substances).\n15. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening.\n16. Participants or their partners planning pregnancy, sperm donation, or oocyte donation during the study and within 6 months after the last study drug administration, and unwilling to use adequate and effective contraception throughout this period.\n17. Participants who cannot avoid driving, operating hazardous machinery, or working at heights from the first dose of study drug until 2 weeks after the last dose.\n18. Any other conditions that, in the Investigator's opinion, render the subject unsuitable for participation in this study.","ALL","18 Years","65 Years",{"count":20,"type":21},232,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-blind, placebo-controlled parallel-group study with a 6-week duration. The long-term study is a multicenter, open-label, single-arm study with a maximum duration of 27 weeks.",[27],"Major Depressive Disorder (MDD)","NOT_YET_RECRUITING","2026-07-28",{"date":31,"type":32},"2026-08-03","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Chengdu Kanghong Pharmaceutical Group Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100649948","phase-3-compare-the-efficacy-and-safety-of-kh607-tablets-versus-vortioxetine-hydrobromide-tablets-in-adult-patients-with-major-depressive-disorder-100649948","NCT07741331","Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder","Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder With Vortioxetine Hydrobromide Tablets as the Active Control","Inclusion Criteria:\n\n1. Age: 18 to 65 years old (inclusive), Male or female.\n2. Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2\u002F296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month\n3. Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).\n4. Patients must have a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline\n5. Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg\u002Fm²\n6. Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.\n7. Participant is willing to stop other antidepressants, antipsychotics, mood stabilizers, sedatives and hypnotics during the trial.\n8. Fully understand the procedures and sigh the informed consent.\n\n   Only for long-term trials:\n9. Subjects who complete the short-term trial (Visit 8 completion), have a ≥50% reduction from short-term trial baseline in MADRS total score at Visit 8, and volunteer to enter the long-term trial.\n\nExclusion Criteria:\n\n1. Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.\n2. A reduction of ≥25% in MADRS total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).\n3. Participants with clinically significant risk of suicide or self-harm, defined as any of the following:\n\n   1. A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;\n   2. An answer of \"Yes\" to Question 4 (active suicidal ideation with intent without specific plan) or Question 5 (active suicidal ideation with specific plan and intent) of the C-SSRS within the past 6 months at screening, or a suicide-related behavior within the past 6 months (any \"Yes\" response for Actual Attempt, Interrupted Attempt, or Aborted Attempt).\n4. Participants meeting any of the following depressive disorder diagnoses:\n\n   1. Poor response to adequate dose and adequate duration (at least 6 weeks) of two or more antidepressants with distinct pharmacological mechanisms during a prior depressive episode (based on Investigator interview, to be adjudicated and documented by the Investigator);\n   2. Depressive disorder secondary to other psychiatric disorders or somatic diseases (e.g., depression induced by hypothyroidism);\n   3. Substance\u002Fmedication-induced depressive disorder.\n5. Participants receiving structured psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other therapies from screening through baseline, who require continuation of such therapies during the study.\n6. Receipt of depression-related neuromodulation therapies within 1 month prior to enrollment, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS).\n7. Prior use of atypical antipsychotics or mood stabilizers during the current depressive episode (e.g., olanzapine, risperidone, quetiapine, aripiprazole, brexpiprazole, ziprasidone, cariprazine, valproate, lithium carbonate).\n8. Use of any strong CYP3A4 inhibitor or inducer within 14 days (or 5 half-lives, whichever is longer) prior to enrollment.\n9. Abnormal hepatic or renal function prior to enrollment: liver function abnormalities (ALT or AST \\>2×ULN), renal function abnormalities (Cr \\>1.5×ULN), or other conditions deemed inappropriate for enrollment by the Investigator.\n10. Positive test results at screening for active hepatitis B (HBV-DNA ≥1000 copies\u002FmL or 200 IU\u002FmL), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody.\n11. 12-lead electrocardiogram (ECG) showing second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF \\>450 ms (male) \u002F 460 ms (female) prior to enrollment; or other conditions unsuitable for participation as judged by the Investigator (e.g., clinically significant tachyarrhythmia requiring intervention).\n12. Severe hypothyroidism (TSH ≥10.0 mIU\u002FL).\n13. Participants with current obstructive sleep apnea and\u002For narcolepsy.\n14. Participants who have known or suspected hypersensitivity to vortioxetine hydrobromide, the investigational product or their excipients, or those with allergic diathesis (defined as allergy to at least two different substances).\n15. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening.\n16. Participants or their partners planning pregnancy, sperm donation, or oocyte donation during the study and within 6 months after the last study drug administration, and unwilling to use adequate and effective contraception throughout this period.\n17. Participants who cannot avoid driving, operating hazardous machinery, or working at heights from the first dose of study drug until 2 weeks after the last dose.\n18. History of seizures, or any other medical conditions associated with an increased seizure risk (e.g., stroke, severe head trauma, significant metabolic disturbances).\n19. History of narrow-angle glaucoma or other conditions resulting in elevated intraocular pressure.\n20. Any other conditions that, in the Investigator's opinion, render the subject unsuitable for participation in this study.",{"count":48,"type":21},326,[24],"This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.",[27],{"date":31,"type":32},{"date":34,"type":21},{"date":55,"type":21},"2028-12",{"name":38,"class":39},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":79,"locationsCount":4},"100643627","phase-1-a-study-to-evaluate-the-effect-of-food-on-the-pharmacokinetic-characteristics-and-safety-profile-of-kh607-in-healthy-chinese-participants-100643627","NCT07634874","A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants","A Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants","Inclusion Criteria:\n\n1. Participants must be healthy and aged ≥18 and \\\u003C45 years at the time of screening visit.\n2. Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg\u002Fm2 and 28.0 kg\u002Fm2 at the time of screening visit.\n3. Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.\n4. Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included\n\nExclusion Criteria:\n\n1. Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.\n2. Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.\n3. Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.\n4. Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.\n5. Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.",true,"45 Years",{"count":67,"type":21},16,[69],"PHASE1","This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.",[72],"Food Effect of KH607 in Chinese Health Participants","2026-06-08",{"date":75,"type":32},"2026-06-09",{"date":77,"type":21},"2026-06",{"date":34,"type":21},{"name":38,"class":39},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100635811","phase-1-a-phase-1-study-of-khn707-tablets-in-healthy-participants-100635811","NCT07557537","A Phase 1 Study of KHN707 Tablets in Healthy Participants","A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of KHN707 Tablets in Chinese Healthy Volunteers","Inclusion Criteria:\n\n* 1.Age: 18 to 45 years old (inclusive), Male or female.\n* 2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19\\~26 kg\u002Fm2 (inclusive).\n* 3\\. Effective contraception measures and no sperm\u002Fegg donation plan from signing the informed consent to 3 months after last dose.\n* 4.Fully understand the procedures and sigh the informed consent.\n\nExclusion Criteria:\n\n* 1\\. Participants with clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, abdominal ultrasound , or chest X-ray as judged by the investigator during screening .\n* 2.Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) and\u002For bilirubin above the upper limit of normal, or creatinine (Cr) above the upper limit of normal at screening or baseline.\n* 3.Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at ScreeningDysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.\n* 4.Participants with medical history of clinically significant conditions that may affect the study per investigator assessment-including but not limited to disorders of the central nervous, cardiovascular, respiratory, digestive, urinary, endocrine, hematologic or immune systems; malignancies; metabolic disorders; any physiological conditions interfering with trial results; or psychiatric\u002Fcerebral dysfunction disorders based on investigator determination of unsuitability..\n* 5.Participants with dysphagia or a history of gastrointestinal diseases or liver\u002Fkidney diseases that, in the investigator's judgment, could affect the pharmacokinetic behavior of the drug.\n* 6\\. Participants who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion.\n* 7\\. Participants who are allergic to the investigational drug or any of its excipients, or have a history of two or more allergies to other drugs, foods, or environmental factors, or have a constitution prone to allergic symptoms such as rash or urticaria.\n* 8\\. Participants with cardiac diseases, including but not limited to congenital long QT syndrome, torsade de pointes, or risk factors for torsade de pointes (e.g., hypokalemia, family history of long QT syndrome), current use of Class IA (e.g., quinidine or procainamide) or Class III (e.g., amiodarone or sotalol) antiarrhythmic drugs or other drugs known to affect the QT interval, or a QTc interval corrected by Fridericia's formula (QTcF) \\>450 ms for males or \\>470 ms for females at screening, or other clinically significant abnormalities on 12-lead ECG.\n* 9\\. Participants who have taken insomnia-related medications or received insomnia-related treatment within 3 months prior to screening.\n* 10\\. Participants who have received vaccination within 30 days prior to screening.\n* 11\\. Participants who have used any drugs\u002Fproducts that affect drug absorption, metabolism, or elimination (e.g., barbiturates, carbamazepine, phenytoin, rifampin, itraconazole, ketoconazole, cimetidine, cyclosporine, macrolides, verapamil, quinolones, azole antifungals, HIV protease inhibitors, gemfibrozil, etc.) within 30 days prior to dosing.\n* 12\\. Participants who have used any medications or health products (including herbal medicines, vitamins) for any reason within 14 days prior to the first dose of the study drug.\n* 13\\. Participants with special dietary requirements who cannot comply with the provided diet and corresponding regulations.\n* 14\\. Participants who have consumed any beverages or foods containing alcohol or caffeine, or engaged in vigorous exercise, or had other factors affecting drug absorption, distribution, metabolism, or excretion within 48 hours prior to the first dose; or participants who do not agree to abstain from tea, coffee, and\u002For caffeinated beverages and foods during the study period.\n* 15\\. Participants who have donated blood or lost a significant amount of blood (\\>400 mL) within 3 months prior to screening.\n* 16\\. Participants who have participated in another clinical trial within 3 months prior to screening.\n* 17\\. Participants who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who cannot refrain from smoking during the study period.\n* 18\\. Participants with a history of alcohol abuse, or a positive alcohol test at study admission; or participants who cannot abstain from alcohol during the study period.\n* 19\\. Participants with a history of drug abuse, or a positive urine drug screen.\n* 20\\. Female participants with a positive pregnancy test, or breastfeeding women.\n* 21\\. Participants who, based on the Columbia-Suicide Severity Rating Scale at screening, or in the investigator's clinical judgment, are at risk of suicide, or have a history of suicidal or self-injurious behavior.\n* 22\\. Participants with other factors deemed ineligible to participate in the trial by the Investigator.",{"count":88,"type":21},38,[69],"This is a single-center, randomized, double-blind, placebo-controlled study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.",[92],"Healthy Adult Participants","2026-04-23",{"date":95,"type":32},"2026-04-29",{"date":97,"type":21},"2026-05",{"date":99,"type":21},"2026-10",{"name":38,"class":39},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100614310","phase-1-efficacy-and-safety-of-khn702-tablets-in-moderate-to-severe-post-operative-pain-subjects-100614310","NCT07277933","Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Subjects","Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Patients: A Randomized, Double-blind, Placebo-Controlled, Phase Ib Trial","Inclusion Criteria:\n\n1. Subjects between the ages of 18 and 75 years, inclusive.\n2. Body mass index (BMI) of 18.0 to 30.0 kg\u002Fm2, inclusive.\n3. Patients scheduled for surgery.\n4. According to the researcher's medical judgment, American Society of Anesthesiologists (ASA) classification≤Grade II.\n5. The subject can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures.\n6. NRS ≥ 4 points within 6 hours after surgery.\n\nExclusion Criteria:\n\n1. Participants experiencing acute or chronic pain unrelated to the surgical site, which the investigator deems may confound the participant's assessment of postoperative pain.\n2. History or evidence of any of the following conditions prior to screening:\n\n   * History of significant cardiovascular or cerebrovascular disease;\n   * Severe respiratory disease history;\n   * Severe Neurological and Psychiatric disease History;\n   * Active peptic ulcer disease, significant vomiting, chronic diarrhea, ileus, malabsorption, or other known conditions that significantly affect drug absorption, distribution, metabolism, or excretion;\n   * Subjects at high risk of bleeding who are deemed unsuitable for this trial by the investigator;\n3. Long-term use of opioids or nonsteroidal anti-inflammatory drugs within the past 30 days prior to screening, or discontinuation of medications affecting analgesic efficacy assessment (except those permitted by the protocol) less than 5 half-life prior to randomization.\n4. Subjects with a history of opioid allergy, or those with a history of allergy to the intraoperative medications specified in the protocol, postoperative rescue analgesics, or known allergies to the investigational drug or its excipients.\n5. Subjects who underwent major surgery within 3 months prior to screening and the investigator determined that it would affect postoperative pain assessment.\n6. Any of the following infectious diseases were present during screening: Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus antibody (HCV Ab) positive, human immunodeficiency virus antibody (HIV Ab) positive, or serum treponema pallidum antibody (TPAb) positive.\n7. History of substance abuse or alcohol abuse within the three months prior to screening .\n8. History of blood donation within the past three months prior to screening.\n9. Individuals who have participated in any clinical research within the past three months prior to screening .\n10. Pregnant or lactating women; women or men of reproductive potential who are unwilling to use contraception throughout the study period; or subjects (including male subjects) planning to conceive within 3 months after study completion.\n11. Subjects with intraoperative blood loss exceeding 1000 mL or those experiencing other severe complications during surgery;\n12. Subjects requiring intensive care following surgery;\n13. Other circumstances deemed unsuitable for participation in this trial by the investigator.","75 Years",{"count":110,"type":21},24,[69],"This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. To preliminarily evaluate the safety and efficacy of KHN702 tablets in moderate to severe post-operative pain patients.",[114],"Postoperative Pain","2025-12-09",{"date":117,"type":32},"2025-12-11",{"date":119,"type":21},"2025-12",{"date":121,"type":21},"2026-02",{"name":38,"class":39},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100596400","phase-1-a-phase-1-study-of-khn702-tablets-in-healthy-subjects-100596400","NCT07044960","A Phase 1 Study of KHN702 Tablets in Healthy Subjects","A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KHN702 Tablets in Chinese Healthy Volunteers","inclusion criteria:\n\n1.Age: 18 to 45 years old (inclusive), Male or female. 2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19\\~26 kg\u002Fm2 (inclusive).\n\n3\\. Effective contraception measures and no sperm\u002Fegg donation plan from signing the informed consent to 3 months after last dose.\n\n4.Fully understand the procedures and sigh the informed consent. exclusion criteria：\n\n1. Have clinically significant medical history or clinical manifestations, including but not limited to the history of any clinically serious disease such as hematological system, circulatory system,digestive system, urinary system, respiratory system, central nervous system,immunology, endocrine system cardiovascular system, malignant tumors, metabolic abnormalities, or any other disease or physiological condition that may interfere with the results .\n2. Subjects with clinically significant abnormalities in vital signs, physical examination, 12 lead electrocardiogram, laboratory examination, abdominal color Doppler ultrasound and chest X-ray during screening period, as determined by the investigator.\n3. Dysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.\n4. Had surgery within 3 months before screening, or planned surgery during the study period, or had surgery that would affect drug absorption, distribution, metabolism, and excretion.\n5. Allergic to the IMP or its excipients, or allergic to two or more other drugs, food and environment, or prone to skin rash, urticaria and other allergic symptoms.\n6. Allergic to natural light \u002F UV, or phototoxic reaction after previous use of specific drugs (such as fluoroquinolones and tetracyclines).\n7. There are risk factors for cardiac disease, including but not limited to congenital long QT syndrome, torsade de pointes or torsade de pointes (such as hypokalemia, hypomagnesemia, family history of long QT syndrome). Currently, class IA \\[such as quinidine or procainamide\\] or class III \\[such as amiodarone or sotalol\\] antiarrhythmic drugs or other drugs known to affect QT interval are used. Or QTc interval (QTCF) corrected according to fridericia's criteria \\> 450 ms in males and \\> 470 ms in females at screening or other 12 lead ECG abnormalities with clinical significance.\n8. Alanine aminotransferase (ALT) and \u002F or aspartate aminotransferase (AST) and \u002F or total bilirubin (TBIL), or serum creatinine (CR) exceeded the upper limit of normal at screening.\n9. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at Screening.\n10. Systolic blood pressure ≥ 140 mmHg and \u002F or diastolic blood pressure ≥ 90 mmHg at screening.\n11. Vaccinated within 30 days before screening.\n12. Any drugs that affects the absorption, metabolism or elimination of the drug has been used within 30 days before administration.\n13. Any drugs or health care products (including Chinese herbal medicine and vitamins) used within 14 days before the first administration of the study.\n14. Have special requirements for diet and cannot comply with the unified diet.\n15. Consumption of foods or juices containing alcohol or caffeine, or having strenuous exercise, or other factors affecting the absorption, distribution, metabolism, excretion of drugs with 48 hours before the first dose. Or disagree to stop drinking tea, coffee and \u002F or caffeinated beverages and foods during the trial.\n16. Average daily smoking of more than 5 cigarettes within the 3 months prior to screening or refuse to abstain from smoking during the trial.\n17. A history of alcohol abuse or alcohol abuse within 6 months before screening (defined as an average intake of alcohol \\> 14 units per week, 1 unit ≈ 285 ml of beer with an alcohol content ≥ 3.5%, or 25 ml of spirits with an alcohol content ≥ 40%, or 85 ml of wines with an alcohol content ≥ 12%), or a positive alcohol test at the screening, or unable to abstain from alcohol during the trial.\n18. Donation of blood or significant blood loss ≥ 400 mL in 3 month prior to screening.\n19. Substance abuse-related disorder or a history of drug, or positive drug screen at screening and Day -1.\n20. Positive pregnancy test, or lactating women.\n21. Participate in other clinical trials within 3 months before screening (participation refers to receiving drug administration or device treatment for the trial).\n22. Subjects with other factors deemed ineligible to participate in the trial by the Investigator.",{"count":131,"type":21},84,[69],"This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs).",[135],"Healthy","2025-06-23",{"date":138,"type":32},"2025-07-01",{"date":140,"type":21},"2025-06-21",{"date":142,"type":21},"2026-04-01",{"name":38,"class":39},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100561411","phase-3-a-double-blind-randomized-comparative-study-of-carliprazine-and-aripiprazole-in-patients-with-acute-schizophrenia-100561411","NCT06589817","A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia","A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects","Inclusion Criteria:\n\n1. Subjects between 18 and 65 years, male and female;\n2. Subjects diagnosed with schizophrenia (according to the DSM-IV criteria);\n3. Subjects with a PANSS Total score between 70-120, with a score of at least 4 on two or more of the items of delusions, hallucinatory behavior, conceptual disorganization, or suspiciousness;\n4. Subjects with a CGI-S score ≥4;\n5. Subjects with a Body Mass Index (BMI) of between 18-40 kg\u002Fm2;\n6. Subjects and subject\\'s legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the scheduled visits, report the adverse events and concomitant medication to investigators, and to be reliably rated on psychiatrically scales，and to provide written informed consent form by subjects and subject\\'s legal guardian or legally acceptable representative.\n\nExclusion Criteria:\n\n1. Other mental illnesses that meet DSM-5 criteria, excluding schizophrenia, including but not limited to: major depressive disorder, bipolar disorder and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, bulimia nervosa\u002Fanorexia nervosa, neurodevelopmental disorders, schizoaffective disorder, and any other mental illness that may affect subject compliance;\n2. Subjects who have been hospitalized for \\> 21 days for the current acute episode.\n3. Subjects with a history of substance abuse or dependence (excluding nicotine or caffeine) in the past 3 months, or those who test positive in the urine drug screening during the screening period (Subjects who test positive in the urine drug screening may be allowed to participate in the study at the researcher\\'s discretion, or may participate if they cease using such substances prior to the trial). Use of narcotic analgesics for a maximum of 3 days is permitted during the trial for clinical medical needs;\n4. Subjects who have history of substance abuse or dependence within 3 months, but excluding caffeine and nicotine. Invesgtigators have the right to decide whether subjects who are positive in urine drug screening can be enrolled in the study, or those who have stopped drug use before screening can be enrolled. During the study, the use of up to 3 days of anesthetic analgesics is allowed for medical purposes.\n5. Subjects with schizophrenia who are considered resistant\u002Frefractory to antipsychotic treatment by history of failure to respond to 2 adequate different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses.\n6. Subjects who have used long-acting antipsychotic drugs (such as risperidone long-acting injection, paliperidone long-acting injection , fluphenazine, aripiprazole long-acting injection , etc.) within 6 months before screening, or subjects who have received ≥15mg aripiprazole treatment within 14 days before screening.\n7. Subjects who have taken \\>200 mg\u002Fday clozapine for any reason, or ≤200 clozapine for the reason other than insomnia, agitation, or anxiety.\n8. Subjects with a history of psychosurgerytherapy, electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months before screening, or those who cannot stop physical therapy during the study.\n9. As judged by the investigator, subjects with risk of severe agitation, violent or destructive behaviors (harming self or othres, suicide).\n10. Subjects with risk for suicidal behavior during the study as determined by the investigator\\'s clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).\n11. Females who are pregnant or breastfeeding, or those are not willing or cannot practice contraceptive methods from the time of signing the ICF to 30 days after the last dose.\n12. Subjects with comorbidities that, in the view of the investigator, may interfere with the implementation of the trial or confound the trial results.\n13. Subjects with a history of ischemic heart disease or myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.\n14. Subjects with history of central nervous system diesease, including but not limited to stroke, tumor of central nervous system, Parkinson's disease, organic brain disorders, epilepsy or seizures, chronic infections, neurosyphilis, or previously suffered from traumatic brain injury.\n15. Subjects with history or presence of clinically significant organic disease, including but not limited to hepatic, renal, pulmonary, cardiovascular, endocrine, neurologic, hematologic, or autoimmunologic diseases.\n16. Subjects with history of ophthalmic disease, such as cataract, intraocular surgery (not including corneal refractive surgery), fundus laser therapy, open-angle or angle-closure glaucoma, retinal or corneal disease, severe ocular trauma or its complications, and acute bacterial or viral eye infections within 1 week before screening.\n17. Subjects with type I diabetes dellitus or uncontrolled type II diabetes mellitus. Subjects with type II diabetes may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:\n\n    * HbA1c \\< 7.0%, and fasting glucose must be ≤ 7.0 mmol\u002FL or non-fasting glucose must be ≤ 11.1 mmol\u002FL at screening, AND\n    * If the non-fasting glucose is \\>11.1mmol\u002FL, subjects must be retested in a fasted state and the retest value must be ≤ 7.0 mmol\u002FL, AND\n    * Subjects have maintained a stable regimen of oral anti-diabetic medication(s) for at least 28 days before screening or diabetes has been well-controlled by diet for at least 28 days before screening, AND\n    * Subjects have not had any hospitalizations within the 2 months before screening due to diabetes or complications related to diabetes, AND\n    * Subjects whose diabetes is not newly diagnosed during screening for the trial.\n18. Abnormal hepatic and renal function at screening, sucha as ALT, AST\\>2×ULN or Cr \\> 1.2 ×ULN.\n\n(18)Clinically significant abnormal finding on ECG at screening, such as QTcF≥450 ms (male) or ≥470 ms (female).\n\n(19)Positive test for HBsAg, HIV antibody, HCV antibody, and TP-Ab at screening.\n\n(20)If other significant abnormalities in laboratory findings and scales at screening, in the opinion of the investigator, subject is unsuitable for enrollment in the study.\n\n(21)Subjects with uncontrolled hypertension, symptomatic hypotension or orthostatic hypotension.\n\n(22)Subjects with history or presence of tardive dyskinesia or neuroleptic malignant syndrome.\n\n(23)Subjects with history of known allergy to carliprazine capsules, aripiprazole tablets, or their excipients, or highly sensitive person (defined as allergies to more than 2 substances); (24)Subject is unsuitable for enrollment in the study in the opinion of the investigator.",{"count":152,"type":21},376,[24],"This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.",[156],"Acute Schizophrenia","2024-09-06",{"date":159,"type":32},"2024-09-19",{"date":161,"type":21},"2024-10",{"date":163,"type":21},"2026-12",{"name":38,"class":39},""]