[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":344},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,39,65,92,113,136,158,178,199,217,239,261,282,303,323],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100643631","phase-2-a-phase-ii-clinical-study-of-syh2068-injection-in-adults-with-elevated-lipoproteina-100643631",false,"NCT07640217","A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)","A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)","Inclusion Criteria:\n\n1. Male or female participants ≥18 years of age;\n2. Elevated Lp(a);\n3. Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;\n4. Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;\n5. Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.\n\nExclusion Criteria:\n\n1. Diseases that significantly affect Lp(a) during screening period,\n2. Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;\n3. Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;\n4. NYHA class III-IV at the time of signing the ICF or LVEF \\\u003C40% during the screening period;\n5. Type 1 diabetes or hereditary hemorrhagic disorder at screening;\n6. History of malignant tumor or suspected malignancy within 5 years prior to screening;\n7. Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;\n8. Allergy to oligonucleotide drugs;\n9. Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;\n10. Female participants who are pregnant or breastfeeding at screening, or female \u002F male participants who plan to conceive during the study and within 1 year after the last dose.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).",[26],"Adult Participants With Elevated Lipoprotein(a)","NOT_YET_RECRUITING","2026-06-05",{"date":30,"type":31},"2026-06-10","ACTUAL",{"date":33,"type":20},"2026-07-30",{"date":35,"type":20},"2028-09-30",{"name":37,"class":38},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100611540","phase-1-a-single-ascending-dose-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-syh2061-100611540","NCT07241910","A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061","A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2061 in Healthy Subjects","Inclusion Criteria:\n\n1. Subjects must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;\n2. Healthy male or female subjects, aged 18 to 55 years (inclusive);\n3. Body mass index ranging from 19.0 to 28.0 kg\u002Fm2 (inclusive), with a body weight of ≥ 50 kg for males and ≥ 45 kg for females;\n4. The results of various examinations, such as physical examination, vital signs, ECG, chest X-ray, abdominal B-scan ultrasound, and laboratory tests at screening are normal or abnormal without clinical significance;\n5. Vaccinated against meningococcal ACYW135 vaccine and pneumococcal vaccine at least 14 days prior to the first dose, or have valid documentation of receiving the respective vaccinations within the past 3 years prior to dosing as evaluated by the investigator.;\n6. Subjects and their partners agree to use effective and reliable contraceptive methods from 14 days before signing the ICF until 6 months after drug administration; male subjects agree not to donate sperm and female subjects agree not to donate ova from signing the ICF until 6 months after study drug administration;\n7. Subjects are able to communicate well with the investigator and can complete the study in accordance with the protocol.\n\nExclusion Criteria:\n\n1. History and\u002For current presence of clinically significant medical conditions, including but not limited to circulatory system disorders, hematological or hematopoietic system disorders, respiratory disorders, endocrine disorders, urinary system disorders, digestive system disorders, neurological or psychiatric disorders, autoimmune diseases, malignant tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results in the opinion of the investigator;\n2. History of splenectomy, or functional or anatomical asplenia;\n3. Known or suspected hereditary or acquired complement deficiency or impaired complement activity, or complement activity below the normal range at screening;\n4. History of meningococcal infection, or positive Neisseria meningitides test at screening;\n5. Subjects who are frequently exposed to Neisseria meningitides (e.g., research, industrial, or clinical laboratory personnel, military personnel during recruit training, daycare center staff, etc.), and those who have traveled to or plan to travel to endemic areas for meningococcal meningitis (e.g., India, sub-Saharan Africa, Saudi Arabia) within 6 months before dosing or during the course of the study;\n6. History of recurrent or chronic infections (e.g., recurrent upper respiratory tract infection, diarrhoea, etc.) or infections requiring systemic antibiotic therapy within 3 months before dosing;\n7. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection including herpes, herpes zoster, or cold sores within 14 days before dosing;\n8. History or current presence of latent or active pulmonary tuberculosis, or positive T-SPOT test at screening;\n9. History of major surgery within 6 months prior to screening, or plan to undergo major surgery during the course of the study;\n10. Subjects with severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or a known history of allergy to the investigational drug components, oligonucleotide drugs, or vaccinations;\n11. Subjects who are allergic to β-lactam antibiotics (e.g., penicillin, cephalosporins) or ciprofloxacin, or have any contraindications, or unwilling to use antibiotic prophylaxis as specified in the protocol;\n12. Intolerance to subcutaneous injection, or presence of abdominal scars (from surgery, burns, etc.) that affect subcutaneous administration, and any skin abnormalities and\u002For tattoos that may affect the safety assessment of the injection site;\n13. Any of the following liver function test results: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), γ-glutamyl transferase (GGT), or alkaline phosphatase (ALP) above the upper limit of normal at screening;\n14. Estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m2 (calculated by the simplified MDRD formula) at screening;\n15. Prolonged QT\u002FQTc interval at screening or baseline (QTcF \\> 450 ms for males, \\> 470 ms for females);\n16. Positive result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus (HIV) antigen\u002Fantibody, or Treponema pallidum antibody;\n17. Use of any prescription drugs, over-the-counter drugs, herbal medicines or vitamin and dietary supplements within 14 days or 5 half-lives (whichever is longer) before dosing;\n18. Received complement inhibitor treatment (e.g., Eculizumab, Crovalimab, etc.) within 6 months or 5 half-lives (whichever is longer) before dosing;\n19. Received live or live-attenuated vaccines within 28 days before dosing, or plan to receive such vaccines during the course of the study (except for vaccinations planned by the study protocol);\n20. Blood loss or blood donation of more than 200 mL within 3 months before screening (except for menstruation in females), or platelet donation within 2 weeks before screening;\n21. History of drug abuse, or use of illicit drugs within 3 months before screening, or habitual use of any psychotropic drugs (including herbal medicines), or a positive urine drug screen;\n22. Regular alcohol consumption within 6 months before screening, defined as weekly alcohol consumption exceeding 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine), or inability to stop alcohol intake as required by the protocol during the study, or a positive blood alcohol test;\n23. Average daily smoking of more than 5 cigarettes (or an equivalent amount of tobacco in e-cigarettes) within 3 months before screening, or unwilling to avoid using any tobacco products as required by the protocol during the study;\n24. Participation in any clinical trial within 3 months before screening (or within 12 months before screening for oligonucleotide drugs)\n25. In addition to the above requirements, female subjects who meet the following criteria should also be excluded: a. Pregnant or lactating women; b. Use of oral contraception within 28 days prior to screening; c. Use of long-acting estrogen and\u002For progesterone injections and\u002For implants within 6 months prior to screening; d. females of childbearing potential who had unprotected sexual intercourse with their partner within 28 days prior to dosing.\n26. Any other conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.",true,"55 Years",{"count":49,"type":20},40,[51],"PHASE1","This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.",[54],"Healthy Subjects","RECRUITING","2026-06-04",{"date":58,"type":31},"2026-06-08",{"date":60,"type":31},"2025-12-23",{"date":62,"type":20},"2027-04-01",{"name":37,"class":38},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100643375","phase-3-a-study-evaluating-aprocitentan-tabletssyh9108-for-the-treatment-of-resistant-hypertension-100643375","NCT07635914","A Study Evaluating Aprocitentan Tablets(SYH9108) for the Treatment of Resistant Hypertension","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Aprocitentan Tablets in the Treatment of Resistant Hypertension","Inclusion Criteria:\n\n1. Male or female participants must be ≥18 years of age.\n2. Participants must have received stable doses of ≥3 antihypertensive agents from distinct pharmacological classes for at least 4 weeks prior to signing the ICF, with such therapy maintained until randomization.\n3. During the screening period and prior to randomization, SiSBP ≥140 mmHg with or without SiDBP ≥90 mmHg, and SiSBP \\\u003C180 mmHg and SiDBP \\\u003C110 mmHg.\n4. Participants are able to understand and cooperate in completing this trial, voluntarily participate in the trial, and sign the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Presence of secondary hypertension.\n2. Have had transient ischemic attack, stroke, unstable angina pectoris, or acute myocardial infarction occurring within the period from 12 months prior to signing the ICF up to randomization.\n3. From screening to prior to randomization, have presence of uncontrolled severe disease or life-threatening disease, or failure to recover from major surgery, or prior thyroid surgery, or presence of malignant tumor, or meeting the criteria for severe hepatic insufficiency at screening.\n4. Have had unstable cardiac disease occurring within the period from 6 months prior to signing the ICF up to randomization.\n5. Have received dialysis at any time prior to signing the ICF or prior to randomization.\n6. Type 1 diabetes.\n7. Compliance with any background antihypertensive drug or placebo is \\\u003C80% or \\>120% during the run-in period.\n8. Use of endothelin receptor antagonists, antihypertensive drugs other than background medications, or other blood pressure-affecting drugs, or high-dose loop diuretics from 4 weeks prior to signing the ICF until randomization; or use of oligonucleotide antihypertensive agents within 1 year prior to signing the ICF.\n9. Hypersensitivity or suspected hypersensitivity to the excipients of the investigational product, endothelin receptor antagonists, or background antihypertensive drugs, or potential hypersensitivity to the investigational product.\n10. Participated in other clinical trials and received at least one dose of study treatment within 12 weeks prior to signing the ICF.\n11. Average night shifts are ≥ 2 times per week during the 4 weeks prior to signing the ICF, the screening period, the run-in period, or the anticipated study period.\n12. History of drug abuse or alcohol abuse within 5 years prior to signing the ICF.\n13. Any of the following test results during the screening period or prior to randomization:\n\n1\\) BMI≥37.5 kg\u002Fm2. 2) Hemoglobin \\\u003C 100 g\u002FL; 3) NT-proBNP ≥ 500 pg\u002FmL; 4) QTcF: \\> 450 ms in males, \\> 470 ms in females; 5) eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m²; 6) ALT or AST \\> 3 × ULN, or total bilirubin \\> 1.5 × ULN; 7) HbA1c \\> 8.0%; 8) TSH outside the normal range and FT3 and\u002For FT4 outside the normal range; 9) Positive HBsAg and positive HBV-DNA, or positive for any of anti-HCV antibody, anti-HIV antibody, anti-Treponema pallidum antibody.\n\n14\\. Female participants of childbearing potential who are pregnant, breastfeeding, or have a positive pregnancy test from signing the ICF until randomization; or female participants of childbearing potential and male participants who plan to conceive (including sperm or egg donation) and\u002For are unable to use effective contraceptive methods during the study period and within 30 days after the end of treatment.",{"count":73,"type":20},382,[75],"PHASE3","Aprocitentan tablets are currently the only endothelin dual receptor antagonist approved internationally for the treatment of resistant hypertension.This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of aprocitentan tablets(SYH9108) in patients with treatment-resistant hypertension (rHTN)",[78],"Resistant Hypertension",[80,81,82,83],"Resistant hypertension","rHTN","Aprocitentan","SYH9108","2026-06-03",{"date":86,"type":31},"2026-06-09",{"date":88,"type":20},"2026-05-31",{"date":90,"type":20},"2030-05-31",{"name":37,"class":38},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100641016","phase-2-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-syh2070-injection-in-participants-with-homozygous-familial-hypercholesterolemia-100641016","NCT07591298","Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Homozygous Familial Hypercholesterolemia","A Multicenter, Open-label Phase II Clinical Trial Evaluating the Efficacy and Safety of SYH2070 Injection in Chinese Participants With Homozygous Familial Hypercholesterolemia","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female, and weight ≥40 kg.\n2. Genetic diagnosis or clinical diagnosis of HoFH.\n3. Receiving stable and tolerable lipid-lowering treatment or other drugs for chronic disease treatment for certain periods before the study, and maintaining the stable -treatments throughout the study.\n4. Fasting serum LDL-C ≥2.6 mmol\u002FL.\n5. Fasting TG during screening is ≤5.6 mmol\u002FL\n6. BMI\\\u003C 40 kg\u002Fm ² during screening\n7. Understand the study procedures, voluntarily participate, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. The genetic diagnosis was for heterozygous familial hypercholesterolemia;\n2. During the screening process, the participant has uncontrolled other diseases that affect blood lipids or lipoproteins (such as nephrotic syndrome, severe liver diseases, glycogen storage disease, systemic lupus erythematosus, Cushing's syndrome, etc.) that the researchers believed would interfere with the accurate assessment of the study validity;\n3. The participant has received or is receiving monoclonal antibodies targeting ANGPTL3 within 5 months or 5 half-lives (whichever is longer) before the LDL-C test during the screening period;\n4. Within 12 months before the LDL-C test during the screening period, use of any ASO or siRNA type drugs;\n5. Those who used any of the following treatments within the specified time limit before the LDL-C test: 1) mipomersen (within 5 months); 2) bepatide acid (within 4 weeks); 3) lipid purification or plasma exchange (within 8 weeks); 4) liver transplantation or CRISPR-based gene editing treatment (at any time);\n6. During the screening period, within 5 months or 5 half-lives (whichever is longer) prior to the LDL-C test, the subject had received significant medications other than lipid-lowering drugs that affected LDL-C levels (such as oral or intravenous glucocorticoids, tacrolimus, cyclosporine, sirolimus, estrogens, vitamin A derivatives, antidepressants, etc.);\n7. At the time of screening, the subject was using medications for thyroid disorders and the use of thyroid disorder medications was stable for less than 12 weeks before the LDL-C test;\n8. History of allergic or suspected allergic reactions to oligonucleotide drugs or excipients of investigational drugs;\n9. History of having a serious adverse cardiovascular event within 180 days before randomization (such as myocardial infarction, stroke or cerebrovascular event, unstable angina pectoris, deterioration of heart failure or hospitalization);\n10. History of having uncontrolled (after drug or ablation therapy) or severe arrhythmias (such as atrial fibrillation with rapid ventricular rate, recurrent or persistent supraventricular or ventricular tachycardia) within 180 days before randomization;\n11. History of having NYHA class Ⅲ-Ⅳ grade heart failure or left ventricular ejection fraction \\\u003C30% within 1 year before randomization or at the time of screening;\n12. History of having type 1 diabetes at the time of screening, or had type 2 diabetes and was using hypoglycemic drugs, and the use of hypoglycemic drugs was stable for less than 12 weeks before the LDL-C test.\n13. History of malignancy (except for cured skin basal cell cancer, etc.) or potential malignancy within the previous 5 years before randomization or at the time of screening;\n14. Major surgery (including CABG, etc.) was performed within 180 days before randomization or was planned to be performed during the study period;\n15. History of drug abuse or alcohol abuse within 1 year before randomization;\n16. Within 90 days before LDL-C testing during the screening period or within 5 half-lives (whichever is longer), the participant has received or plans to receive other clinical research treatments (drugs or devices) during the study period;\n17. During the screening period, the participant met any of the following criteria:\n\n    SBP ≥ 160 mmHg, or DBP ≥ 100 mmHg (untreated or after drug stabilization treatment); ALT or AST \\> 3.0 × ULN, or total bilirubin \\> 1.5 × ULN; CK \\> 2.5 × ULN; QTcF interval: male \\> 450 ms, female \\> 470 ms; eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula, see Appendix 13.6); HBsAg positive and HBV DNA positive; or HCV antibody positive and HCV RNA positive; or positive for HIV antibody, anti-Neisseria meningitidis antibody; TSH \\\u003C LLN, or TSH \\> 1.5 ULN; HbA1c \\> 9%;\n18. Female participants with reproductive capacity who were in pregnancy or lactation at the time of screening, or had a positive pregnancy test result before randomization; or male and female participants with reproductive capacity who had a fertility plan (including sperm donation, egg donation) and\u002For were unable to take effective contraceptive measures during the study period until after the end of treatment;\n19. Other situations considered by the investigator as not suitable for participating in this trial (including poor compliance, etc.).",{"count":100,"type":20},18,[23],"This trial is a multicenter, open-label, phase II clinical study, aiming to evaluate the efficacy and safety of SYH2070 injection in participants with HoFH.",[104],"Diagnosed With HoFH","2026-05-09",{"date":107,"type":31},"2026-05-15",{"date":109,"type":20},"2026-05-24",{"date":111,"type":20},"2027-09-30",{"name":37,"class":38},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100635030","steady-state-bioequivalence-study-of-aripiprazole-for-injection-in-patients-with-schizophrenia-100635030","NCT07547384","Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.","A Randomized, Open-label, Two-period, Crossover, Steady-state Bioequivalence Study of Aripiprazole for Injection Following Multiple Dosing in Patients With Schizophrenia","Inclusion Criteria:\n\n* 1\\. Aged 18 to 65 years (inclusive), male or female.\n* 2\\. Patients diagnosed with schizophrenia according to ICD-10 criteria, with a Positive and Negative Syndrome Scale (PANSS) total score ≤ 70, judged as clinically stable for at least 28 days prior to screening (no medication changes or hospitalization due to condition changes).\n* 3\\. Receiving treatment with ≤ 2 other oral antipsychotic medications, which must have been at a stable dose for ≥ 14 days before the first study injection (excluding prohibited medications).\n* 4\\. Body weight ≥ 45 kg for females and ≥ 50 kg for males; Body Mass Index (BMI) between 18.5 and 35.0 kg\u002Fm² (inclusive).\n* 5\\. Subject or partner has no pregnancy plan and agrees to use effective non-drug contraception during the study and for six months after the last dose.\n* 6\\. Subjects and their legal guardians voluntarily sign the Informed Consent Form (ICF) and are able to comply with all study requirements.\n\nExclusion Criteria:\n\n* 1.Diagnosis of any psychiatric disorder other than schizophrenia according to ICD-10 criteria.\n* 2.History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurological diseases that, in the investigator's judgment, would affect participation in the study.\n* 3.Patients with Parkinson's disease, Lewy body dementia, or dementia-related psychosis.\n* 4.History or presence of Neuroleptic Malignant Syndrome (NMS).\n* 5.History or presence of epilepsy or convulsive disorders (except childhood febrile seizures), or a history of stroke or transient ischemic attack (TIA) within one year before signing the Informed Consent Form (ICF).\n* 6.Concurrent tardive dyskinesia (or history) or severe akathisia.\n* 7.Esophageal motility dysfunction or dysphagia with a potential risk of aspiration pneumonia.\n* 8.Cardiovascular Risks: Congenital long QT syndrome; presence of uncontrolled or significant cardiovascular disease, including NYHA Class II or higher heart failure, unstable angina, myocardial infarction, or significant arrhythmia\u002Ffrequent ventricular premature beats within 6 months before the first dose; QTcF \\> 450 ms in males or \\> 470 ms in females; presence of risk factors for Torsades de Pointes or sudden death (such as bradycardia, clinically significant hypokalemia, or current use of QTc-prolonging medications; excluding bradycardia judged by the investigator to be risk-controllable and stable after treatment, corrected hypokalemia, or instances where QTc-prolonging medications are discontinued or evaluated as acceptable for stable use) or other clinically significant ECG abnormalities judged by the investigator as potentially affecting subject safety or interfering with study participation.\n* 9.Blood Pressure Abnormalities: Poorly controlled hypertension (SBP \\> 160 mmHg and\u002For DBP \\> 100 mmHg after stable antihypertensive treatment); symptomatic hypotension; or orthostatic hypotension (SBP drop ≥ 20 mmHg or DBP drop ≥ 10 mmHg within 3 minutes of standing during screening or baseline).\n* 10.Glycosylated hemoglobin (HbA1c) level ≥ 7% at screening or baseline.\n* 11.Laboratory Abnormalities: 1) TBiL \\> 1.5 × ULN, or AST\u002FALT \\> 2 × ULN; 2) CLcr \\\u003C 90 mL\u002Fmin; 3) WBC \\\u003C 3 × 10⁹\u002FL, Neutrophils \\\u003C 1.5 × 10⁹\u002FL, Platelets \\\u003C 75 × 10⁹\u002FL, RBC \\\u003C 3.0 × 10¹²\u002FL, or Hemoglobin \\\u003C 100 g\u002FL.\n* 12.Positive results for HBsAg, HCV-Ab, HIV-Ab, or Syphilis-Ab that, in the investigator's judgment, affect study participation.\n* 13.Severe Suicide Risk: 1) Positive response to item 4 or 5 of \"suicidal ideation\" on C-SSRS within the past 6 months; 2) History of suicidal behavior within the past 6 months; or 3) Judged by the investigator to have a severe suicide risk.\n* 14.Received electroconvulsive therapy (ECT) or invasive psychiatric treatment within 28 days before signing the ICF.\n* 15.History of Blood Loss: Blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month before signing the ICF.\n* 16.Major surgery within 3 months before signing the ICF, or planned surgery during the study or within one month after study completion.\n* 17.Other Clinical Studies: Participation in any other drug clinical study within one month before the first dose (except for aripiprazole BE studies).\n* 18.Long-acting Injectable (LAI) History: Prior treatment with non-aripiprazole LAIs where the interval since the last dose is shorter than the labeled dosing interval of that LAI; or a requirement for other LAIs during the study.\n* 19.Medication Contraindications: Use of Chlorpromazine or Thioridazine within 28 days before the first dose; or use of strong\u002Fmoderate CYP3A4 or CYP2D6 inhibitors or inducers within 14 days or five half-lives (whichever is longer).\n* 20.Consumption of foods or beverages rich in xanthines, grapefruit, or caffeine within 48 hours before the first dose, or other special diets that could affect drug pharmacokinetics.\n* 21.History of drug abuse, drug usage, or positive drug screening within one year before signing the ICF.\n* 22.Chronic Alcohol Consumption: Males \\> 14 units\u002Fweek, females \\> 7 units\u002Fweek (1 unit ≈ 10g pure alcohol).\n* 23.History of needle phobia or blood phobia judged by the investigator to be clinically significant.\n* 24.Known or suspected hypersensitivity to the study drug or any of its components.\n* 25.Female Status: Women who are pregnant, breastfeeding, or planning to become pregnant (excludes those postmenopausal for ≥ 1 year or surgically sterilized).\n* 26.Other conditions that the investigator deems unsuitable for participation in the study.","65 Years",{"count":122,"type":20},116,[124],"NA","The primary objective of this study is to evaluate the bioequivalence of aripiprazole for injection (Test product, 400 mg) compared with Abilify Maintena® (Reference product, 400 mg) at steady state in patients with schizophrenia.his is a multi-center, randomized, open-label, two-period, crossover study. Approximately 116 clinically stable patients will be enrolled and randomly assigned to one of two treatment sequences: Sequence A (Test-Reference) or Sequence B (Reference-Test). In each 141-day study period, participants will receive five injections of either the test or reference product at 28-day intervals to achieve steady-state plasma concentrations. Bioequivalence, safety and tolerability of the study drug will be assessed in this study.",[127],"Schizophrenia","2026-04-16",{"date":130,"type":31},"2026-04-23",{"date":132,"type":20},"2026-04-05",{"date":134,"type":20},"2027-11-05",{"name":37,"class":38},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100625335","phase-3-a-study-to-evaluate-the-safety-efficacy-of-syh2053-as-monotherapy-in-chinese-participants-with-non-familial-hypercholesterolemia-or-mixed-hyperlipidemia-100625335","NCT07421297","A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia","A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia","Inclusion Criteria:\n\n1. 、Age ≥18 years (inclusive);\n2. 、Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):① Low risk: LDL-C ≥130 mg\u002FdL（3.4 mmol\u002FL）and LDL-C\\\u003C188 mg\u002FdL（4.9 mmol\u002FL）; ②Moderate risk: LDL-C ≥ 100 mg\u002FdL (2.6 mmol\u002FL) and LDL-C\\\u003C188 mg\u002FdL（4.9 mmol\u002FL）; 3、At screening (based on local laboratory results), Fasting serum Triglyceride (TG)\\\u003C500 mg\u002FdL（5.6 mmol\u002FL） 4、Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；\n2. A documented history of established atherosclerotic cardiovascular disease (ASCVD), defined as a history of: acute coronary syndrome (myocardial infarction or unstable angina), chronic coronary syndrome, or prior coronary revascularization (e.g., PCI or CABG); ischemic stroke or transient ischemic attack (TIA); or significant peripheral artery disease (PAD). PAD includes conditions such as chronic limb-threatening ischemia, acute limb ischemia, or atherosclerotic disease in other major arteries (e.g., carotid, vertebral, subclavian, renal, or mesenteric arteries)；\n3. Treatment with short-acting lipid-lowering therapies (e.g., statins, fibrates, bempedoic acid, ezetimibe, bile acid sequestrants, niacin, omega-3 fatty acids) or any preparation of unknown composition with lipid-lowering intent (including over-the-counter, traditional, or herbal medicines) within 90 days prior to screening; or treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with inclisiran or any other RNA-based lipid-lowering therapy (e.g., siRNA, antisense oligonucleotide) within the past 2 years before screening;\n4. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;\n5. At screening, Systolic blood pressure (SBP) \\> 160 mmHg or diastolic blood pressure (DBP) \\> 100 mmHg（either in untreated patients or in those on stable medical therapy） ;\n6. History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization;\n7. At screening, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²（as calculated by the CKD-EPI equation）;\n8. At screening, Creatine Kinase (CK) \\> 3 × ULN ;\n9. At screening, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN or Total Bilirubin (TBIL), \\> 1.5 × ULN （unless attributable to Gilbert's syndrome）;\n10. At screening, prolonged QT\u002FQTcF interval at Screening Period or prior to Randomization (QTcF \\> 450 ms for males, \\> 470 ms for females)\n11. Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;\n12. At screening, HbA1c \\> 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;\n13. History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;\n14. History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week \\[1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content\\]);\n15. Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;\n16. Any condition that, in the Investigator's opinion, may interfere with the conduct of the study, including but not limited to: a. presence of any disease within 6 months prior to Screening through the study period that may interfere with study results; b. any other reason that would prevent the subject from completing the study or that makes them inappropriate for inclusion;",{"count":144,"type":20},760,[75],"The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia .\n\nThis trial plans to enroll 760 Participants.",[148],"Non-familial Hypercholesterolemia and Mixed Hyperlipidemia","2026-04-01",{"date":151,"type":31},"2026-04-07",{"date":153,"type":31},"2026-02-28",{"date":155,"type":20},"2028-01-31",{"name":37,"class":38},2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":64},"100630890","a-bioequivalence-study-of-pp3m-in-patients-with-schizophrenia-100630890","NCT07493551","A Bioequivalence Study of PP3M in Patients With Schizophrenia","A Randomized, Open-label, Multicenter, Two-formulation, Multiple-dose, Parallel-design Bioequivalence Study of Paliperidone Palmitate Injection (3M) in Chinese Patients With Schizophrenia","Inclusion Criteria:\n\n* 18 to 65 years old (including 18 and 65 years old).\n* Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening.\n* Weight: male patients with weight ≥50.0 kg, female patients with weight ≥45.0 kg, with the body mass index of 19.0\\~35.0 kg\u002Fm\\^2 (including 19.0 and 35.0).\n* Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline.\n* Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline.\n* Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Be allergic, or have a clear history of allergies to trial drugs and components.\n* Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator.\n* History of tardive dyskinesia.",{"count":166,"type":20},260,[124],"To evaluate the bioequivalence of the test formulation paliperidone palmitate injection (3M) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and the reference formulation paliperidone palmitate injection (3M) (brand name: Invega Trinza) by Janssen Pharmaceutica N.V. under multiple-dose administration.",[127],"2026-03-23",{"date":172,"type":31},"2026-03-25",{"date":174,"type":31},"2024-10-09",{"date":176,"type":20},"2026-12-31",{"name":37,"class":38},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100628716","phase-3-a-study-to-evaluate-the-syh2053-injection-in-patients-with-heterozygous-familial-hypercholesterolemia-hefh-100628716","NCT07465263","A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)","A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial","Inclusion Criteria:\n\n1. Male or female participants ≥18 years of age.\n2. HeFH.\n3. Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) .\n4. Maintained a low-fat diet for ≥4 weeks before signing the ICF.\n5. Fasting LDL-C at screening ≥ 2.6 mmol\u002FL or ≥ 1.4 mmol\u002FL without ASCVD or with ASCVD.\n6. Fasting TG ≤5.6 mmol\u002FL at screening.\n\nExclusion Criteria:\n\n1. HoFH or suspected HoFH.\n2. Use of medications that significantly affect LDL-C levels.\n3. Hypersensitivity or suspected allergy to oligonucleotide drugs or excipients of the investigational product.\n4. Major adverse cardiovascular events (MACE) within 180 days before signing the ICF; history of hemorrhagic stroke; or extreme-risk ASCVD at screening.\n5. Uncontrolled (by medication\u002Fablation) or severe arrhythmias within 180 days before signing the ICF.\n6. NYHA Class III-IV heart failure or LVEF \\\u003C40% within 1 year before signing ICF or at screening.\n7. Type 1 diabetes.\n8. Uncontrolled severe illness or conditions that may interfere with study results\u002Fincrease risk at screening, according to investigator's judgment.\n9. History of malignancy or underlying malignancy within 5 years before signing ICF or at screening.\n10. Major surgery within 180 days before signing ICF or planned during the study.\n11. History of drug\u002Falcohol abuse within 5 years before signing ICF.\n12. Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) before signing ICF, or planned during the study.\n13. Any of the following at screening:\n\n1）SBP ≥160 mmHg or DBP ≥100 mmHg. 2）ALT\u002FAST \\>3× ULN, or total bilirubin \\>1.5× ULN. 3）CK \\>2.5× ULN. 4）QTcF interval: \\>450 ms for male, \\>470 ms for female. 5）eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m². 6）HBsAg positive with HBV DNA positive; or HCV\u002Fsyphilis\u002FHIV antibody positive. 7）TSH\\\u003CLLN, or TSH\\>ULN. 8）HbA1c \\>8.5%. 14.Pregnancy\u002Flactation or planned parenthood, and\u002For without effective contraception for female and male participants of childbearing potential from the study to 3 months after the end of treatment.\n\n\\-",{"count":186,"type":20},135,[75],"Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease (ASCVD). This trial aims to evaluate the SYH2053 Injection in patients with HeFH.",[190],"Heterozygous Familial Hypercholesterolemia (HeFH)","2026-03-17",{"date":193,"type":31},"2026-03-19",{"date":195,"type":20},"2026-03-31",{"date":197,"type":20},"2028-05-31",{"name":37,"class":38},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":216,"locationsCount":64},"100625334","phase-3-a-study-to-evaluate-the-safety-efficacy-of-syh2053-in-chinese-participants-with-non-familial-hypercholesterolemia-and-mixed-hyperlipidemia-on-a-background-of-lipid-lowering-therapy-100625334","NCT07421284","A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy","A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy","Inclusion Criteria:\n\n1. Age of 18 - 75 years (inclusive);\n2. Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;\n3. Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):\n\nWith a history of ASCVD:\n\n1. Very high risk: 55 mg\u002FdL (1.4 mmol\u002FL) ≤ LDL-C \\\u003C 188 mg\u002FdL (4.9 mmol\u002FL);\n2. Extremely high risk: LDL-C ≥ 70 mg\u002FdL (1.8 mmol\u002FL);\n\n   Without a history of ASCVD:\n3. Moderate to high risk: LDL-C ≥ 100 mg\u002FdL (2.6 mmol\u002FL);\n4. Low risk: LDL-C ≥ 130 mg\u002FdL (3.4 mmol\u002FL); 4.Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；\n2. Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy within the past 2 years before screening;\n3. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;\n4. Systolic blood pressure (SBP) \\> 180 mmHg or diastolic blood pressure (DBP) \\> 110 mmHg during the Screening Period or prior to Randomization;\n5. History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF \\\u003C 40% within 180 days before screening;\n6. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² during the Screening Period or prior to Randomization;\n7. Creatine Kinase (CK) \\> 3 × ULN at Screening Period;\n8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN or Total Bilirubin (TBIL), \\> 1.5 × ULN at Screening Period or prior to Randomization;\n9. Prolonged QT\u002FQTcF interval at Screening Period or prior to Randomization (QTcF \\> 450 ms for males, \\> 470 ms for females)\n10. Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;\n11. HbA1c \\> 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;\n12. History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;\n13. History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week \\[1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content\\]);\n14. Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;\n15. Any condition that, in the Investigator's opinion, may interfere with the conduct of the study, including but not limited to: a. presence of any disease within 6 months prior to Screening through the study period that may interfere with study results; b. any other reason that would prevent the subject from completing the study or that makes them inappropriate for inclusion;",{"count":207,"type":20},900,[75],"The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.\n\nThis trial plans to enroll 900 Participants.",[148],"2026-02-12",{"date":213,"type":31},"2026-02-19",{"date":195,"type":20},{"date":155,"type":20},{"name":37,"class":38},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":64},"100611541","phase-1-a-single-ascending-dose-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-syh2070-injection-100611541","NCT07241923","A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2070 Injection","A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2070 Injection in Healthy Subjects","Inclusion Criteria:\n\n1. Subjects must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;\n2. Sex: Male or female;\n3. Age: 18-60 years (inclusive);\n4. Body mass index (BMI) in the range of 19 to 30 kg•m\\^2 \\[BMI = weight\u002Fheight\\^2 (kg•m\\^2)\\] (inclusive), with a weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);\n5. Fasting serum TG ≥150 mg\u002FdL (1.7 mmol\u002FL) and ≤ 500 mg\u002FdL (5.6 mmol\u002FL), and LDL-C ≥70 mg\u002FdL (1.8 mmol\u002FL) and \\\u003C 190 mg\u002FdL (4.9 mmol\u002FL) during the screening and baseline periods;\n6. Subjects must maintain stable die, exercise, and other lifestyle habits from 4 weeks prior to screening until the end of the study, with no planned changes to diet, exercise or weight loss programs;\n7. Subjects must be able to communicate well with the investigator and can complete the study according to the protocol requirements.\n\nExclusion Criteria:\n\n1. History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug components (N-acetylgalactosamine, sodium hydroxide, phosphoric acid) or oligonucleotide drugs;\n2. Use of antibody drugs and\u002For oligonucleotide drugs targeting PCSK9\u002FANGPTL3\u002FApoC-III within 12 months prior to screening;\n3. Current and\u002For history of clinically significant medical conditions, including but not limited to circulatory, hematological or hematopoietic, respiratory, endocrine, urinary, digestive system diseases, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results, as judged by the investigator;\n4. History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study;\n5. History of bariatric surgery within 12 months prior to screening;\n6. Have clinically significant abnormalities in vital signs, physical examination, electrocardiogram, and laboratory tests (excluding lipid parameters);\n7. Estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2 at screening;\n8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) \\>1.5× upper limit of normal (ULN) at screening (one retest allowed within 1 week);\n9. Prolonged QT \u002F QTc interval at screening or baseline (QTcF \\> 450 ms);\n10. Positive result for any of HBsAg, HCV antibody, syphilis antibody, and HIV antibody;\n11. Blood loss or donation \\>200 mL within 3 months prior to screening (excluding menstruation for females), and\u002For platelet donation within 2 weeks;\n12. Use of any drugs, health supplements, vitamins, or dietary supplements known to affect lipid metabolism within the longer of either: (a) 28 days prior to dosing; (b) 7 half-lives of the drug; (3) the duration of the agent's pharmacological effect, including but not limited to statins, fish oil, high-purity omega-3, prescription-dose niacin, fibrates, or anti-estrogen therapy;","60 Years",{"count":226,"type":20},48,[51],"This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.",[230],"Healthy Subjects (HS)","2025-11-28",{"date":233,"type":31},"2025-12-01",{"date":235,"type":31},"2025-11-15",{"date":237,"type":20},"2027-11-01",{"name":37,"class":38},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":64},"100600390","phase-1-bioequivalence-study-of-paclitaxel-protein-bound-particles-for-injectable-suspension-albumin-bound-in-breast-cancer-patients-100600390","NCT07096869","Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients","A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients","Inclusion Criteria:\n\n* 1\\) Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as subjects, and sign informed consent prior to the commencement of any study procedure;\n* 2\\) Male and female, ages 18-75 years both inclusive;\n* 3\\) Subjects with breast cancer confirmed by histopathology and\u002For cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; ②This treatment criteria (NCCN guidelines and CSCO guidelines - Breast cancer) is used to determine whether the subjects are suitable for paclitaxel for injection (albumin-bound) monotherapy. ③Subjects received standard treatment without conditions and were judged to benefit from injectable paclitaxel (albumin-binding) monotherapy;\n* 4\\) ECOG Score ≤ 2 points;\n* 5\\) The expecting life span ≥ 3months;\n* 6\\) The results of blood, liver and kidney function tests are within the following ranges: Absolute neutrophil counts (ANC) ≥ 1.5×10\\^9\u002FL Platelets (PLT) ≥ 100×10\\^9\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Total bilirubin (TBIL) ≤ 1.5×ULN Alanine transaminase (ALT), Aspartate aminotransferase (AST)≤×ULN (for patients with liver metastasis, ≤ 5×ULN) Creatinine clearance (CrCL)≥ 60 mL\u002Fmin\n* 7\\) The subject has no fertility plan (including sperm donation and egg donation) for at least 6 months from the signing of informed consent to the last dose and voluntarily takes non-drug effective contraceptive measures;\n* 8\\) Subjects can communicate well with the investigators, understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* 1\\) A severe allergy or hypersensitivity to paclitaxel or human albumin;\n* 2\\) In addition to cancer, have any other serious liver, kidney\u002Fgenitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding diathymia or clotting disorders) diseases Patients with a known or present history of the disease who are deemed unsuitable for enrollment by the investigators;\n* 3\\) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;\n* 4\\) Pregnant or lactating female subjects;\n* 5\\) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen\u002Fantibody positive; treponema pallidum antibody positive and rapid plasma reaction hormone (RPR) positive;\n* 6\\) Those who used chemical small molecule anti-tumor drugs (including endocrine therapy), biological macromolecular anti-tumor drugs, biological therapy, radiotherapy or needed to combine other anti-tumor drugs for treatment during the study period within 4 weeks before the first dose;\n* 7\\) Electrocardiogram shows significant abnormality, and\u002For baseline QTcF interval is \\> 470 ms;\n* 8\\) Pre-screening sensory neuropathy\u002Fperipheral neuropathy are ≥ grade 2;\n* 9\\) Blood donation or significant blood loss (\\> 400 mL) within 90 days before - screening;\n* 10\\) Ingestion of an inhibitor or inducer of CYP2C8 or CYP3A4 within 28 days prior to dosing (acceptable drug use is stable in homeostasis, that is, the dosing regimen remains unchanged; However, the use of moderate-strong inhibitory agents\u002Fmoderate-strong inducers should be prohibited), or drugs (including Chinese herbs) that can affect the absorption, distribution, metabolism and excretion behavior of the study drugs or special diets (such as products containing caffeine or xanthine, grapefruit fruits and products containing grapefruit ingredients, etc.);\n* 11\\) Those who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit ≈ 360 mL for beer, or 45 mL for spirits, or 150 mL for wine) or who could not stop drinking during the study period or who are breath-positive for alcohol;\n* 12\\) Smoking \\> 5 cigarettes per day within 3 months prior to screening or smoking cannot be stopped during the study period;\n* 13\\) Any clinically significant abnormal results in the subjects' vital signs, physical examination, clinical laboratory examination (unless otherwise specified in the protocol), 12-lead electrocardiogram (ECG) and other examination results that the investigator deems unsuitable for enrollment;\n* 14\\) Within 6 months prior to screening, there is a history of drug abuse (except regular use of pain medications due to cancer pain) or positive drug abuse screening;\n* 15\\) Toxicity caused by using of anti-tumor drugs prior to enrolment do not return to ≤ grade 1 or baseline levels, except for alopecia;\n* 16\\) Subjects receiving granulocyte-stimulating growth factor treatment within 2 weeks before dosing;\n* 17\\) Subjects who have participated in any clinical trial within 1 month before screening (start from the time of the last dose);\n* 18\\) Any other circumstances determined by the investigator to be inappropriate are not suitable for participation in this study","75 Years",{"count":248,"type":20},28,[51],"The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.",[252],"Bioequivalence","2025-07-24",{"date":255,"type":31},"2025-07-31",{"date":257,"type":31},"2025-06-26",{"date":259,"type":20},"2026-02-25",{"name":37,"class":38},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":64},"100580840","phase-1-study-of-syh2062-injection-in-healthy-chinese-volunteers-100580840","NCT06842537","Study of SYH2062 Injection in Healthy Chinese Volunteers","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers","Inclusion Criteria:\n\n1. Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.\n2. Age of 18 - 55 years (inclusive).\n3. BMI: 19.0-26.0 kg\u002Fm\\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.\n4. Has Systolic blood pressure (SBP) ≥100 mmHg and \\\u003C140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and \\\u003C90 mmHg at screening;\n5. The subjects can communicate well with the investigators and complete the trial according to protocol.\n\nExclusion Criteria:\n\nAllergic constitution, or known history of allergy to the components of the study drug or similar drugs.\n\n2 Subjects with the following diseases of clinical significance (including but not limited to diseases of the circulatory system, diseases of the blood or hematopoietic system, diseases of the respiratory system, diseases of the endocrine system, diseases of the urinary system, diseases of the digestive system, neurological or mental diseases, infections, tumors, serious injuries).\n\n3 Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.\n\n4 Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and\u002For platelet donation within 2 weeks prior to initial administration.\n\n5 Positive urine drug screening. 6 Those who smoked more than 5 cigarettes per day within 3 months prior to screening and\u002For did not agree to refrain from using any tobacco products during hospitalization.\n\n7 Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and\u002For those who could not stop drinking alcohol during their hospitalization, and\u002For test positive for breath alcohol.",{"count":269,"type":20},46,[51],"The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers",[273],"Healthy Chinese Volunteers","2025-04-28",{"date":276,"type":31},"2025-04-30",{"date":278,"type":31},"2025-03-01",{"date":280,"type":20},"2025-12-31",{"name":37,"class":38},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100557888","phase-3-efficacy-and-safety-study-of-aprepitant-injection-for-prevention-of-post-operative-nausea-and-vomiting-100557888","NCT06543966","Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting","Inclusion Criteria:\n\nAge ≥18 and ≤75 years old; 18 \\\u003C BMI≤30kg\u002Fm\\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.\n\nexpected or agreed to stay in the hospital for 24 hours or more after surgery;\n\nExclusion Criteria:\n\ndiagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;",{"count":290,"type":20},486,[75],"A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,",[294],"Post-operative Nausea and Vomiting (PONV)","2024-08-05",{"date":297,"type":31},"2024-08-09",{"date":299,"type":20},"2024-10-28",{"date":301,"type":20},"2026-03-28",{"name":37,"class":38},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":224,"maxAge":246,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":64},"100530116","phase-3-a-bridging-study-of-liposomal-cytarabine-daunorubicin-in-treating-olderly-patients-with-treatment-naive-high-risk-secondary-acute-myeloid-leukemia-100530116","NCT06182592","A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia","A Randomized, Multi-center, Open-label Phase III Bridging Study to Compare Efficacy of Liposomal Cytarabine-Daunorubicin for Injection With Cytarabine and Daunorubicin in Treating Older Patients With High-Risk (Secondary) Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Able to understand the study and voluntarily sign informed consent.\n* Male or female between 60-75 years of age (inclusive).\n* Pathological diagnosis of AML according to 2022 WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) and fulfill of one of the following standards:\n\n  1. Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease;\n  2. AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS;\n  3. AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL;\n  4. De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Laboratory values meet the following criteria:\n\n  1. Serum creatinine≤2 × ULN;\n  2. Serum total bilirubin≤2 × ULN, ≤3 × ULN for patients with liver involvement;\n  3. Serum alanine aminotransferase or aspartate aminotransferase≤3 × ULN, ≤5 × ULN for patients with liver involvement.\n* Cardiac function (LVEF) ≥ 50% by echocardiography or MUGA.\n* QTcF (Fridericia's) for male\\\u003C450 ms, for female\\\u003C470 ms at screening.\n* Male and female of childbearing potential must agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia; or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.\n* Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS\u002FMPN are not eligible.\n* History of other malignancy within 3 years before randomization, expect for cancers that have been cured (basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix and breast or prostate cancer with Gleason score of 6).\n* Patients with clinical evidence of active CNS leukemia.\n* Prior treatment for AML (except for hydroxyurea) or stem-cell transplantation.\n* Administration of any therapy for MDS (conventional or investigational) within 2 weeks prior to of the first dose of study drug; use of hydroxyurea for the purpose of inhibiting rapid tumor proliferation within 24 hours before the first dose. Toxicities associated with prior MDS therapy have not recovered to grade 1 or less prior to start of treatment.\n* Any major surgery or radiation therapy within 4 weeks.\n* Patients with previous cumulative exposure to anthracyclines \\>368 mg\u002Fm\\^2 daunorubicin (or equivalent drug equivalent dose level).\n* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.\n* Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by NYHA Criteria (Class Ш or Ⅳ staging).\n* Active or uncontrolled infection.\n* Current evidence of invasive fungal infection (blood or tissue culture).\n* Patients with known HIV, hepatitis B or hepatitis C infection.\n* Patients who are hypersensitive to cytarabine, daunorubicin or liposomal products.\n* Patients with a history of Wilson's disease or other copper-metabolism disorders.\n* Participation in another clinical trial or treatment with any investigational drug within 28 days prior to screening.\n* Any patients whom the investigator believes will not be a good candidate for the study.",{"count":19,"type":20},[75],"The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.",[314],"High-risk (Secondary) Acute Myeloid Leukemia","2023-12-27",{"date":317,"type":31},"2023-12-28",{"date":319,"type":20},"2024-01",{"date":321,"type":20},"2026-08",{"name":37,"class":38},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100494406","phase-3-clinical-study-of-mitoxantrone-hydrochloride-liposome-injection-combined-with-capecitabine-versus-capecitabine-monotherapy-in-patients-with-recurrent-metastatic-nasopharyngeal-carcinoma-who-failed-platinum-containing-treatment-100494406","NCT05717764","Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Treatment","A Randomized, Open-label, Positive-controlled, Multicenter Phase Ш Study Comparing Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Therapy","Inclusion Criteria:\n\n1. Willing to participate in the study and sign the informed consent form (ICF).\n2. Age ≥ 18 years.\n3. Nasopharyngeal carcinoma confirmed by histopathology.\n4. Recurrent metastatic nasopharyngeal carcinoma that has previously failed treatment with first-line platinum-containing standard regimens and\u002For second-line standard regimens.\n5. At least one evaluable lesion at baseline according to RECIST 1.1 criteria; The area should not have received previous radiotherapy, or there is evidence that the lesion has made definite progress after radiotherapy.\n6. Eastern Cooperative Oncology Group (ECOG) score 0-1.\n7. Toxic reaction caused by any previous antitumor treatment has recovered to grade 1 or below (except for alopecia, pigmentation, or other toxicities deemed by the investigator to pose no safety risk to the patient).\n8. Adequate main organ function.\n9. Female patients must have a negative blood HCG test (except for menopause and hysterectomy), Female patients of childbearing age and their partners must use effective contraception (For example: combination hormones \\[containing estrogen and progesterone\\] to suppress ovulation, progestogen contraception to suppress ovulation, intrauterine device, intrauterine hormone release system, bilateral tubal ligation, vasectomy, avoidance of sexual activity, etc) during the trial and within 6 months of the end of the last dose.\n10. Male patients and their partners agree to use one of the contraceptive measures described in Article 9.\n\nExclusion Criteria:\n\n1. Severe allergy to mitoxantrone or liposome; Previous severe, unexpected reactions to fluorouracil or known allergy to fluorouracil or to any excipients of capecitabine.\n2. Previous treatment regimens containing capecitabine for recurrent or metastatic nasopharyngeal carcinoma; Patients with locally advanced nasopharyngeal carcinoma have previously experienced disease recurrence or metastasis during or within 6 months of use of capecitabine.\n3. Patients with brain or meningeal metastasis.\n4. Expected lifetime \\\u003C 3 months.\n5. Patients with active hepatitis B, hepatitis C or HIV.\n6. Active bacterial infection, fungal infection, viral infection, or interstitial pneumonia requiring systemic therapy within 1 week prior to the first administration of the study drug.\n7. Antitumor therapy such as chemotherapy, small-molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to initial administration of the study drug; Received Chinese patent drugs with antitumor activity within 14 days prior to administration.\n8. Have received other investigational drugs within 4 weeks prior to initial administration.\n9. Patients had major surgery within 3 months prior to initial dosing or plan to have major surgery during the study period.\n10. Severe embolic events, such as cerebrovascular accidents (including transient ischemic attacks) and pulmonary embolism, occurred within 6 months prior to screening.\n11. Other active malignant tumors within 2 years prior to the first study drug administration.\n12. Abnormal heart function, including:\n\n    Long QTc syndrome or QTc interval \\>480 ms; Complete left bundle branch block, second-degree or third-degree atrioventricular block; Severe, uncontrolled arrhythmias requiring medication; History of chronic congestive heart failure with NYHA ≥ grade 3; Cardiac ejection fraction less than 50% or lower than the lower limit of the laboratory test range within 6 months prior to screening; CTCAE version 5.0 ≥ grade 3 valvular heart disease; Uncontrolled hypertension (defined as measuring systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>90 mmHg when medically controlled); Myocardial infarction, unstable angina, history of severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to screening.\n13. Prior treatment with doxorubicin or other anthracyclines and the cumulative doxorubicin doses greater than 350 mg\u002Fm\\^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone).\n14. Pregnant or lactating women.\n15. Have any serious and\u002For uncontrollable medical conditions that, as determined by the investigator, may affect the patient's participation in the study.\n16. Have severe gastrointestinal disorders that affect the ingestion, transport, or absorption of medications.\n17. Other situations that the investigator determines to be inappropriate for participation.",{"count":331,"type":20},500,[75],"This is a randomized, open-label, positive-controlled, multicenter Phase Ш study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in patients with recurrent metastatic nasopharyngeal carcinoma.",[335],"Recurrent Metastatic Nasopharyngeal Carcinoma","2023-01-29",{"date":338,"type":31},"2023-02-08",{"date":340,"type":20},"2023-02",{"date":342,"type":20},"2027-09",{"name":37,"class":38},""]