[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Salubris Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":311},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,69,88,115,139,166,189,214,237,259,285],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641323","phase-2-a-phase-ii-clinical-trial-of-efficacy-and-safety-of-sal0140-at-different-doses-in-patients-with-uncontrolled-hypertension-100641323",false,"NCT07654140","A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension","Inclusion Criteria:\n\n1. Patients 18-75 years old, male or female.\n2. Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and \\\u003C180 mmHg.\n3. Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN).\n4. Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and \\\u003C180 mmHg.\n5. Voluntarily participate in this study and sign the informed consent form.\n6. Agree to comply with contraception and fertility restrictions of this study.\n\nExclusion Criteria:\n\n1. Severe hypertension (msSBP ≥ 180 mmHg and\u002For msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.\n2. Compliance with study drug during the run-in period was less than 80% or greater than 120%.\n3. Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke.\n4. Positive results for any of human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (HCV), treponema pallidum antibody (TP); or positive hepatitis B surface antigen (HBsAg) with HBVDNA ≥ 1000 IU\u002FmL.\n5. Patients with active malignant tumors.\n6. Patients receiving hemodialysis or adhering to strict salt restriction therapy.\n7. History of adrenal insufficiency.\n8. History of solid organ or bone marrow transplantation.\n9. Gastrointestinal diseases or post-gastrointestinal surgery.\n10. Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications.\n11. History of drug abuse or alcohol abuse.\n12. Blood donation or significant blood loss.","ALL","18 Years","75 Years",{"count":20,"type":21},252,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in uncontrolled hypertension.",[27],"Uncontrolled Hypertension",[29,30,31,32],"Hypertension","Aldosterone Synthase Inhibitor","Renin","Angiotensin","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-12-09",{"date":41,"type":21},"2027-07-31",{"name":43,"class":44},"Shenzhen Salubris Pharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100642270","phase-2-a-phase-ii-clinical-trial-of-efficacy-and-safety-of-sal0140-at-different-doses-in-patients-with-chronic-kidney-disease-100642270","NCT07647133","A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Aged ≥18 years , regardless of gender.\n2. Diagnosed with chronic kidney disease (CKD)\n3. Urine albumin-creatinine ratio (UACR) of ≥300 mg\u002Fg and ≤5000 mg\u002Fg.\n4. Serum potassium≥ lower limit of normal (LLN) and ≤4.8 mmol\u002FL.\n5. Receiving stable background concomitant medication at screening\n6. Mean seated office systolic blood pressure (msSBP) ≥120 mmHg.\n7. Morning serum cortisol \\>3 μg\u002FdL.\n8. Voluntarily participate in the trial and provide written informed consent.\n9. Agree to comply with trial contraception and reproductive restrictions.\n\nExclusion Criteria:\n\n1. Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.\n2. Had acute kidney injury or end-stage renal disease, received peritoneal dialysis, hemodialysis or kidney transplantation; or planned to undergo kidney transplantation or chronic renal replacement therapy during the study period.\n3. Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and\u002For mean seated office diastolic blood pressure (msDBP) ≥110 mmHg. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.\n4. History or diagnostic evidence of other secondary hypertension.\n5. Serum sodium \\\u003C135 mmol\u002FL .\n6. Subjects with severe hepatobiliary diseases.\n7. Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).\n8. Receiving blood transfusion for anemia.\n9. Poorly controlled diabetes mellitus.\n10. Morbid obesity.\n11. Had cardiovascular disease that precludes participation in the study or any electrocardiogram (ECG) abnormalities deemed by the investigator to substantially increase the subject's risk.\n12. History of adrenal insufficiency.\n13. History of solid organ or bone marrow transplantation.\n14. Medication compliance \\\u003C80% or \\>120%.\n15. History of acute diabetic complications.\n16. Prior exposure to rituximab or cytotoxic chemotherapeutic agents.\n17. Prior exposure to systemic immunosuppressive drugs.\n18. Recent use of traditional Chinese medicine (TCM) or proprietary Chinese preparations indicated for urinary protein reduction.\n19. Recent use of strong CYP3A inhibitors or CYP3A inducers.\n20. Active malignancy or past medical history of malignant tumor.\n21. Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.\n22. History of substance abuse or chronic alcohol abuse.\n23. Recent blood donation or major blood loss (\\>400 mL), or clinically diagnosed hypovolemia.\n24. Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.\n25. Participation in any other clinical trial and receipt of an investigational product within 3 months.\n26. Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.\n27. Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and\u002For safety assessment.",{"count":54,"type":21},249,[24],"This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).",[58],"Chronic Kidney Disease",[58,30,31],"NOT_YET_RECRUITING","2026-06-09",{"date":63,"type":37},"2026-06-15",{"date":63,"type":21},{"date":66,"type":21},"2027-12-31",{"name":43,"class":44},2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":87,"locationsCount":45},"100642963","phase-2-a-phase-ii-clinical-trial-of-efficacy-and-safety-of-sal0140-at-different-doses-in-patients-with-primary-aldosteronism-100642963","NCT07646535","A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism","Inclusion Criteria:\n\n1. Aged ≥18 years , regardless of gender.\n2. Diagnosed with primary aldosteronism (PA).\n3. Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.\n4. Receiving stable background antihypertensive therapy.\n5. Serum potassium tested at local laboratory ≥3.0 mmol\u002FL and \\\u003C5.0 mmol\u002FL.\n6. Morning serum cortisol \\>3 μg\u002FdL.\n7. Voluntarily participate in the trial and provide written informed consent. Agree to comply with trial contraception and reproductive restrictions.\n\nExclusion Criteria:\n\n1. Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and\u002For mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.\n2. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.\n3. History or diagnostic evidence of other secondary hypertension.\n4. Prior surgical resection for adrenal adenoma.\n5. Medication compliance \\\u003C80% or \\>120%.\n6. PA complicated with acute coronary syndrome, myocardial infarction, percutaneous coronary intervention or stroke.\n7. Receiving treatment with potassium-binding agents.\n8. Any clinically significant abnormal laboratory findings that, in the Investigator's opinion, may interfere with the evaluation of efficacy and\u002For safety endpoints of the study.\n9. Subjects with severe hepatobiliary diseases.\n10. Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).\n11. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n12. Morbid obesity.\n13. Receiving blood transfusion for anemia.\n14. History of adrenal insufficiency.\n15. History of solid organ or bone marrow transplantation.\n16. Prior exposure to rituximab or cytotoxic chemotherapeutic agents.\n17. Recent use of strong CYP3A inhibitors or CYP3A inducers.\n18. Concomitant use of antihypertensive drugs, or other chemical drugs, biological products, traditional Chinese medicines or natural products deemed inappropriate by the Investigator.\n19. Active malignancy or past medical history of malignant tumor.\n20. Patients on hemodialysis or strict salt-restricted diet.\n21. Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.\n22. Known or suspected hypersensitivity to aldosterone synthase inhibitors; known contraindication or hypersensitivity to any background concomitant medications.\n23. History of substance abuse or chronic alcohol abuse.\n24. Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.\n25. Recent blood donation or major blood loss (\\>400 mL), or clinically diagnosed hypovolemia.\n26. Participation in any interventional clinical trial with investigational product within 3 months prior to screening (or within 5 half-lives of the investigational product, whichever is longer); or enrollment in any medical device clinical trial with implanted\u002Fused study device.\n27. Night shift work within 3 days prior to study visit and within 3 days before ambulatory blood pressure monitoring.\n28. Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.\n29. Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and\u002For safety assessment.",{"count":77,"type":21},50,[24],"This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.",[81],"Primary Aldosteronism",[81,30,31],"2026-06-08",{"date":34,"type":37},{"date":34,"type":21},{"date":66,"type":21},{"name":43,"class":44},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":45},"100638487","phase-2-a-phase-ii-clinical-trial-of-the-safety-and-efficacy-of-sal056-at-different-doses-and-dosing-regimens-100638487","NCT07579936","A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens","Evaluation of the Safety and Efficacy of SAL056 (Recombinant Human Parathyroid Hormone [1-34] for Injection [56.5 μg]) at Different Doses and Dosing Regimens: A Multicenter, Randomized, Open-Label, Parallel-Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n1.Female, with independent mobility, 45 years ≤ age ≤ 80 years; 2.Natural menopause for ≥3 years, or surgical menopause for ≥3 years (surgery must be performed after age 40); for women with surgical menopause, follicle-stimulating hormone \\>40 mIU\u002FmL is required; 3.18 ≤ body mass index ≤ 30 kg\u002Fm²; 4.Previous definitive diagnosis of osteoporosis; 5.Patients who are able to independently go to the hospital to receive injections of the investigational drug; 6. Voluntarily participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Received teriparatide treatment within 1 month prior to screening;\n2. Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;\n3. Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU\u002FL \\\u003C thyroid-stimulating hormone ≤ 10.0 mIU\u002FL but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;\n4. Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term\u002Fcontinuous use of digitalis glycosides such as digoxin;\n5. Patients with severe renal disease (serum creatinine \\>1.5 times the upper limit of normal), uncontrolled hypertension \\[systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg\\], severe heart disease (such as myocardial infarction, unstable angina pectoris, heart failure with NYHA functional class III-IV, severe arrhythmias, etc.), cerebral infarction (excluding lacunar cerebral infarction) or occlusive arteriosclerosis, malignant tumors, and those with other serious underlying diseases;\n6. Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing;\n7. Abnormal laboratory findings detected during the screening period, including any of the following abnormal indicators:\n\n1\\) Alkaline phosphatase \\>1.3 times the upper limit of normal; 2) Alanine aminotransferase or aspartate aminotransferase \\>3.0 times the upper limit of normal; 3)Total bilirubin \\>1.5 times the upper limit of normal; 4) Glycated hemoglobin ≥8.5%; 5)White blood cell count \\\u003C3.0×10⁹\u002FL, or hemoglobin \\\u003C100g\u002FL, or platelet count \\\u003C90×10⁹\u002FL; 6)Parathyroid hormone \\>1.5 times the upper limit of normal; 8. Positive for hepatitis C virus antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; or positive for hepatitis B surface antigen (HBsAg) with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥1×103 copies\u002FmL (if HBsAg is positive and peripheral blood HBV DNA titer \\\u003C1×103 copies\u002FmL, the trial participant is eligible if the investigator considers the participant's chronic hepatitis B to be in a stable phase and will not increase the risk to the trial participant); 9. History of major surgery (excluding fracture surgery) within 6 months prior to signing the informed consent form, or planned major surgery during the study period; 10. Known history of organ transplantation; 11. History of drug abuse within 6 months prior to informed consent; 12. Individuals with known allergy to the investigational drug; 13. Patients who have previously received radiation therapy to the skeletal system; 14. Individuals with mental illness or cognitive impairment due to any cause; 15. Patients deemed unsuitable to participate in this study by researchers based on risk-benefit considerations.","FEMALE","45 Years","80 Years",{"count":99,"type":21},200,[24],"This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.",[103],"Postmenopausal Women With Osteoporosis",[103,105,106],"high risk of fracture","Teriparatide","2026-05-05",{"date":109,"type":37},"2026-05-12",{"date":111,"type":37},"2026-04-30",{"date":113,"type":21},"2026-11-30",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":45},"100630344","phase-1-bioequivalence-study-of-sacubitril-alisartan-amlodipine-tablets-100630344","NCT07486453","Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets","Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets Versus Sacubitril Alisartan Calcium Tablets Combined With Amlodipine Besylate Tablets","Inclusion Criteria:\n\n* Study participants aged 18 to 60 years (inclusive of 18 and 60 years), both male and female\n* Body weight not less than 50 kg. Body Mass Index (BMI) = weight (kg) \u002F height\\^2 (m\\^2). BMI must be within the range of 19 to 26 kg\u002Fm\\^2 (inclusive of the limit values)\n* The study participant is able to communicate well with the research staff, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign a written informed consent form\n* The study participant or their partner has no plans for pregnancy, sperm donation, or egg donation during the study period and for 3 months after drug administration, and must agree to use at least one acceptable effective contraceptive method\n* During the screening period: 110 mmHg ≤ seated systolic blood pressure (SBP) \\\u003C 140 mmHg, 65 mmHg ≤ seated diastolic blood pressure (DBP) \\\u003C 90 mmHg, and no orthostatic hypotension.\n\nExclusion Criteria:\n\n* Those who smoked more than 5 cigarettes per day on average in the 3 months prior to the trial and are unable to quit smoking during the trial period.\n* Pregnant or breastfeeding women, or female study participants of childbearing potential with a positive blood pregnancy screening.\n* Known allergic reaction to angiotensin II receptor antagonists (such as sacubitril\u002Fvalsartan sodium, alisartan ester, losartan, valsartan) and calcium channel blockers (such as nifedipine, amlodipine), or their excipients; or allergic constitution (multiple drug and food allergies).\n* Alcoholics or those who frequently consumed alcohol within the 3 months prior to screening, i.e., consuming more than 14 standard alcohol units per week (1 unit alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or those with a positive alcohol breath test, or those unable to stop using any alcohol-containing products during the trial period.\n* Those who donated blood or experienced significant blood loss (\\>400 mL), used blood products, or received a blood transfusion within the three months prior to screening.\n* Those who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period, or subjects with a history of surgery affecting drug absorption, distribution, metabolism, or excretion.\n* Those who have been vaccinated within 3 months prior to screening.\n* History of hypotension, syncope, needle fainting, swallowing difficulties, any gastrointestinal disease affecting drug absorption, or any history of conditions increasing hemorrhagic risk, such as acute gastritis or gastroduodenal ulcers.\n* Use of any drug that alters hepatic enzyme (CYP3A4) activity or inhibitors of transporters (OAT1\u002F3, OATP1B1\u002F3) within 28 days prior to screening.\n* Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days prior to screening.\n* Participation in any drug clinical trial and administration of any other investigational drug, or use of investigational products, within 3 months prior to taking the study drug.\n* Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram (ECG), or laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation profile, and four infectious disease markers) at screening.\n* Any other disease or medical history considered by the investigator as unsuitable for participation in this study, such as disorders of the central nervous, cardiovascular, digestive, respiratory, urinary, hematopoietic, immune systems, psychiatric conditions, or metabolic abnormalities.\n* Consumption of chocolate, any caffeine-containing, or xanthine-rich foods or beverages within 48 hours prior to taking the study drug.\n* History of drug abuse or substance abuse, or a positive urine drug screen at screening.\n* Those with special dietary habits who cannot comply with the unified dietary requirements, or those with lactose intolerance (e.g., history of diarrhea after drinking milk).\n* Any other reason considered by the investigator as unsuitable for enrollment.",true,"60 Years",{"count":125,"type":21},60,[127],"PHASE1","This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril\u002FValsartan\u002FAmlodipine Tablets (240mg\u002F5mg) versus Sacubitril\u002FValsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult study participants.",[130],"Primary Hypertension","2026-03-18",{"date":133,"type":37},"2026-03-20",{"date":135,"type":21},"2026-03-09",{"date":137,"type":21},"2026-04-25",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":45},"100606382","phase-4-pharmacokinetic-study-of-allisartan-isoproxil-tablets-in-healthy-chinese-participants-100606382","NCT07174830","Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants","Inclusion Criteria:\n\n* Healthy male or female adults aged 18 to 65 years (inclusive).\n* Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 25.0 kg\u002Fm2.\n* Seated systolic blood pressure (SBP) ≥100 mmHg and \\\u003C140 mmHg, seated diastolic blood pressure (DBP) ≥70 mmHg and \\\u003C90 mmHg, and no orthostatic hypotension at screening.\n* Participants must be able to communicate effectively with the investigator, fully understand the trial's objectives and requirements, voluntarily participate in the clinical trial, and provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected allergy to Allisartan Isoproxil, , other ARBs, or any excipients of this formulation.\n* Abnormal findings in physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that are clinically significant as judged by the investigator.\n* Any medical history or current condition that may impact participant safety assessments or the pharmacokinetics of the investigational drug, including but not limited to disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric conditions, metabolic abnormalities, or prior gastrointestinal surgery.\n* Used any prescription drugs, over-the-counter medications,Chinese herbal medicines, or food supplements within 14 days prior to screening.\n* Participants with hyponatremia, hyperkalemia, or hypovolemia;\n* Participants with a history of orthostatic hypotension or syncope;\n* Participants who have received any vaccinations within 4 weeks prior to screening.\n* Participants who consume excessive amounts of strong tea, coffee, and\u002For caffeinated beverages (≥8 cups\u002Fday, 1 cup=250 mL), or have consumed such beverages within 48 hours prior to dosing, or cannot abstain during the trial;\n* Participants with habitual intake of xanthine-rich or grapefruit-containing products, or have consumed such products within 48 hours prior to dosing, or cannot abstain during the trial;\n* Female participants who are pregnant or breastfeeding;\n* Participants (or their partners\u002Fspouses) who plan pregnancy, sperm\u002Fegg donation, or refuse to use at least one acceptable contraceptive method during the trial and for 3 months post-study ;\n* Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.\n* Heavy smokers or Participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study.;\n* Heavy drinkers or Participants with an average alcohol consumption of more than 14 units per week (1 unit=360 mL beer\u002F45 mL 40% spirits\u002F150 mL wine) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or beverages during the study;\n* Participants with a positive result for drug abuse test at screening, or a history of drug abuse(past 5 years), or recent illicit drug use (within 3 months prior to screening);\n* Participants who have participated in other drug\u002Fdevice trials and received investigational products within 3 months prior to screening;\n* Participants who have donated blood (≥400 mL), received transfusions, or used blood products within 3 months prior to screening;\n* Participants with difficult venous access or intolerance to repeated venipuncture;\n* Participants with difficulty swallowing study medication; Participants deemed by investigators to have poor compliance or other factors unsuitable for trial participation.","65 Years",{"count":147,"type":21},54,[149],"PHASE4","This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy Chinese subjects at single dose administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of Allisartan Isoproxil Tablets.",[152],"Healthy Participants",[154,155,156,157],"Allisartan Isoproxil Tablets","safety","tolerability","PK profile","2025-09-15",{"date":160,"type":37},"2025-09-16",{"date":162,"type":37},"2025-09-06",{"date":164,"type":21},"2026-02-16",{"name":43,"class":44},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":45},"100599060","phase-4-enarodustat-tablets-at-different-initial-doses-for-anemia-in-non-dialysis-ckd-patients-100599060","NCT07079579","Enarodustat Tablets at Different Initial Doses for Anemia in Non-dialysis CKD Patients","A Prospective, Single-arm, Open-label Study to Evaluate Different Initial Doses of Enarodustat Tablets for the Treatment of Anemia in Patients With Non-dialysis Chronic Kidney Disease","Inclusion Criteria:\n\n* Patients who meet all the following criteria can be enrolled in this study:\n\n  1. Male or female patients aged 18-75 years (inclusive);\n  2. Body weight: 45-100 kg (inclusive);\n  3. Stage 3-5 non-dialysis CKD complicated with renal anemia during the screening period, with an eGFR of 10-60 mL\u002Fmin\u002F1.73 m2 (exclusive) (calculated by CKD-EPI equation);\n  4. Criteria for Hb levels at screening and baseline\n\n  \u003C!-- -->\n\n  1. ESA-naïve population: Patients who do not receive ESA treatment in the past 12 weeks, with the Hb level greater than or equal to 70 g\u002FL and less than 100 g\u002FL;\n  2. ESA-treated population: Patients who have received ESA treatment for at least 8 weeks, with the Hb level greater than or equal to 100 g\u002FL and less than or equal to 120 g\u002FL; 5.Female patients shall take contraceptive measures during the study; Patients who voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients who meet any one of the following criteria shall be excluded from the study:\n\n  1. Patients with SF ≤100 μg\u002FL and TSAT ≤20% at screening;\n  2. Patients who are expected to start renal replacement therapy in the next 6 months as judged by the investigator;\n  3. Patients with systemic hematologic disorders (e.g., myelodysplastic syndrome and aplastic anemia, etc.) or non-CKD-related anemia (hemolytic anemia, hemorrhagic anemia, cancer related anemia, etc.);\n  4. Patients with a 1.5-fold increase in serum creatinine during the screening period;\n  5. Patients who have received hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) within 8 weeks before screening;\n  6. Patients with polycystic kidney disease;\n  7. Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at the screening visit);\n  8. Patients with congestive cardiac failure (New York Heart Association \\[NYHA\\] Class III or above) or unstable angina;\n  9. Patients who have experienced myocardial infarction, transient ischemic attack, cerebral infarction (except asymptomatic cerebral infarction) or venous thromboembolism (pulmonary embolism or deep vein thrombosis) from 24 weeks before screening to the first dose of the investigational drug;\n  10. Patients with severe hepatobiliary disorders (e.g., AST or ALT \\>2.5 × upper limit of normal (ULN) at the screening visit, patients with hepatic cirrhosis or total bilirubin ≥1.5 × ULN at the screening visit);\n  11. Patients who have received red blood cell transfusion from 12 weeks before screening to the first dose of the investigational drug;\n  12. Patients who have received growth hormone, thyroid hormone, testosterone enanthate or methandienone from 12 weeks before screening to the first dose of the investigational drug;\n  13. Patients who will undergo elective ophthalmic surgery in the next 6 months;\n  14. Patients with severe hyperparathyroidism (e.g., iPTH ≥500 pg\u002FmL at the screening visit);\n  15. Patients with severe infections (e.g., active pulmonary tuberculosis and fungal infection, etc.);\n  16. Patients suspected of having other non-infectious chronic inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis and coeliac disease, etc.);\n  17. Patients with a positive result for HIV, HCV or Treponema pallidum antibody, or with a positive result for HBsAg and HBV DNA ≥1,000 U\u002FmL;\n  18. Patients with a history of malignant tumors (including hematological malignancies) in the past 5 years;\n  19. Patients with a history of severe drug allergy (e.g., anaphylactic shock) or hypersensitivity to other HIF-PHIs;\n  20. Patients with a history of drug or alcohol abuse in the past two years;\n  21. Patients who have received other investigational drugs (or study drugs) or received investigational medical devices (or study devices) from 12 weeks before the screening visit to the first dose of the investigational drug, or are participating in other interventional clinical studies (medical behaviors beyond routine diagnosis and treatment, implemented for study purposes) and receiving treatment;\n  22. Patients who are pregnant, lactating or have the possibility of pregnancy (based on the results of the pregnancy test at the screening visit, the investigator cannot rule out the possibility of pregnancy);\n  23. Patients with any medical conditions that, in the investigator's judgment, may pose a safety risk, may confound efficacy or safety evaluation, or may interfere with their participation in the study.",{"count":174,"type":21},120,[149],"To evaluate the rationality of different initial doses of enarodustat for the treatment of anemia in ND-CKD patients",[178],"Renal Anemia in Non-dialysis Chronic Kidney Disease",[178,180],"Enarodustat","2025-07-14",{"date":183,"type":37},"2025-07-23",{"date":185,"type":21},"2025-08",{"date":187,"type":21},"2027-12",{"name":43,"class":44},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":45},"100596909","phase-1-sal0140-safety-tolerability-pharmacokinetic-and-pharmacodynamic-study-in-a-healthy-chinese-population-100596909","NCT07051603","SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population","A Phase 1, Randomized, Double-Blind Placebo-Controlled Single and Multiple Dose Study Plus Food Effect Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SAL0140 in Healthy Chinese Subjects","Inclusion Criteria:\n\n* Subjects has fully understood and voluntarily signed the informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;\n* Male or female aged 18-65 years (including 18 and 65 years old);\n* Male body weight ≥50kg, female body weight ≥45kg and body mass index (BMI) between 19.0 - 26.0 kg\u002Fm2 (including 19.0 and 26.0, BMI = weight(kg) \u002F height(cm)2) at screening;\n* All examinations (including physical examination, vital signs, laboratory tests, ECG, chest X-ray (anterior and lateral views), etc.) show no abnormalities or minor abnormalities deemed non clinical signiant by the investigator;\n\nExclusion Criteria:\n\n* Subjects with orthostatic tachycardia or orthostatic hypotension at screening; or those with a history of orthostatic hypotension symptoms (such as dizziness, fatigue, blurred vision, pallor upon standing) or orthostatic tachycardia symptoms (such as dizziness, palpitations, tremors, general weakness, blurred vision, exercise intolerance when standing);\n* Subjects have used corticosteroids within 3 months prior to dosing;\n* Subjects with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;\n* Subjects with prolonged QTcF interval (\\>450msec) on ECG;\n* Subjects with potassium levels above the upper limit of normal (\\>ULN) or sodium levels below the lower limit of normal (\\\u003CLLN) in biochemistry tests;\n* Subjects with known allergies to excipients in the study drug or history of severe allergic reactions (including food, drugs, insect bites, etc.);\n* Subjects with any disease history or current condition that may affect the safety evaluation or drug disposition of the study participant, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, psychiatric conditions, metabolic disorders, gastrointestinal surgery (except appendectomy), etc.;\n* Subjects have undergone gastric surgery, vagotomy, bowel resection, or any surgery that may interfere with gastrointestinal motility, pH, or absorption;\n* Subjects received live or attenuated vaccines within 4 weeks prior to screening;\n* Subjects consume excessive tea, coffee, and\u002For caffeinated beverages (more than 8 cups, 1 cup = 250 mL) daily, or have consumed these beverages within 48h prior to dosing, or cannot stop consuming during the trial;\n* Subjects have taken any prescription drugs, over-the-counter medications, Chinese herbs, or dietary supplements (including vitamins, health foods, etc.) within 14 days prior to dosing;\n* Subjects with a history of long-term consumption of xanthine-rich or grapefruit-containing beverages or foods, or who have consumed any xanthine-rich or grapefruit products within 48h prior to dosing;\n* Subjects have smoked within 3 months prior to screening, or cannot stop using any tobacco products during the trial;\n* Subjects have participated in other clinical trials and taken any investigational drugs within 3 months prior to screening;\n* Subjects have donated blood or lost blood ≥400 mL, received blood transfusion or blood products within 3 months prior to screening;\n* Subjects have had unprotected sexual intercourse within 2 weeks prior to screening; study participants and their spouses or partners who have pregnancy plans, sperm\u002Fegg donation plans during the study period until 1 month after dosing, or do not agree to use at least one of the following acceptable effective contraception methods:\n\n  * Correctly placed intrauterine device;\n  * Male\u002Ffemale condom used in combination with topical spermicide (i.e., foam, gel, film, cream, or suppository);\n  * Male vasectomy or vas deferens ligation;\n  * Female bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion surgery (occlusion surgery verified effective by relevant instruments);\n  * Abstinence.\n* Pregnant or lactating women, or women of childbearing potential with positive pregnancy screening results;\n* Subjects are alcoholic or regular drinkers within 3 months prior to screening, i.e., weekly alcohol consumption exceeding 14 standard units (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine) or positive baseline alcohol breath test, or cannot stop using any alcohol-containing products during the trial;\n* Subjects positive drug abuse screening or history of drug abuse or previous use of illicit drugs;\n* Subjects tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody; Subjects deemed by the investigator to have poor compliance or other factors that unsuitable for participation in this trial.",{"count":197,"type":21},82,[127],"The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.",[27],[202,203,204,205],"SAL0140","Uncontrolled hypertension","Pharmacokinetic","Pharmacodynamic","2025-07-03",{"date":208,"type":37},"2025-07-04",{"date":210,"type":37},"2025-06-09",{"date":212,"type":21},"2026-02",{"name":43,"class":44},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":4},"100579950","phase-1-bioequivalence-study-of-fluvastatin-sodium-extended-release-tablets-in-healthy-participants-100579950","NCT06830954","Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants","Inclusion Criteria:\n\n* Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.\n* Participants are able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial.\n* Healthy male or female adults aged 18 to 65 years (inclusive).\n* Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg\u002Fm2 (inclusive; BMI = body weight ÷ height2).\n* No abnormalities or only slight abnormalities not clinically significant of tests\u002Fexaminations as judged by the investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK) must not exceed the upper limit of the normal reference range.\n\nParticipants or their partners must not have any pregnancy plans during the study and for three months after the last administration of the investigational drug. They must voluntarily take effective contraceptive measures (the use of contraceptive medications is prohibited during the study) to avoid pregnancy for themselves or their partners, and participants must not donate sperm or eggs (ovum and oocytes) for reproductive or assisted reproductive purposes.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.\n* Participants who have a history of clinically significant acute allergy to drug or food within two weeks prior to screening, or have an allergic constitution (e.g., allergy to two or more drugs, food, or pollens), or have a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or have possible or definite allergy, hypersensitivity or clinically significant reactions to investigational drugs or excipients judged by the investigator.\n* Participants with any disease (e.g., acute gastritis, peptic ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., haemorrhage intracranial, hemorrhage intraocular, haemophilia, angiohaemophilia, etc.) that may change or aggravate haemorrhagic diathesis as judged by the investigator.\n* Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.\n* Drug abuse, alcohol abuse, or tobacco addiction:\n\nParticipants with a history of drug abuse, or a positive result for drug abuse test at screening; Participants with an average alcohol consumption of more than 14 units per week (1 unit ≈ 17.7 mL of ethanol, i.e., 1 unit ≈ 360 mL of beer with 5% alcohol content or 45 mL of spirit with 40% alcohol content or 150 mL of wine with 12% alcohol content) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or beverages during the study; Participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study.\n\n•Subjects who used any of the following food, medications, or treatments prior to the first dose: Used any drugs that inhibit or induce liver drug metabolism (e.g., inducers such as barbiturates, carbamazepine, phenytoin, rifampicin; inhibitors such as SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within four weeks prior to the first dose.; Female participants who have used long-acting estrogen or progestin injections or implants within six months prior to screening; Used any prescription drugs, Chinese herbal medicines, or food supplements (including vitamins, health-care food, etc.) within 2 weeks prior to the first dose; Habitual consumption of grapefruit or grapefruit juice-containing products within 1 week prior to screening, or unwillingness to abstain from grapefruit-containing foods or beverages from 48 hours before dosing of the first period to 48 hours after dosing of the fourth period; Consumption of xanthine-rich foods or beverages (e.g., chocolate, cocoa beans, coffee) within 48 hours prior to the first dose, or unwillingness to abstain from xanthine-rich foods or beverages from 48 hours before the dosing of first period to 48 hours after dosing of the fourth period.\n\nConsumed tea, coffee, and\u002For foods or beverages containing caffeine within 48 hours prior to the first dose, or do not agree to refrain from consuming tea, coffee, and\u002For foods or beverages containing caffeine from 48 hours before dosing of the first period until 48 hours after dosing of the fourth period.\n\n* Participants who participated or are participating in any interventional clinical study (including investigational drug or vaccine, and other clinical studies of fluvastatin or other cohorts of this study) and received drugs within 3 months prior to screening.\n* Participants with dysphagia or special dietary requirements who cannot adhere to a standardized diet.\n* Participants who received live vaccines, attenuated vaccines, or vaccines containing any live viral components within 3 months prior to screening, or those who plan to receive any of these vaccines during the study.\n* Participants who experienced blood donation (including component blood donation) or blood loss ≥ 400 mL within 3 months prior to screening; or blood donation (including component blood donation) or blood loss ≥ 200 mL or blood transfusion within 1 month prior to screening; or those who plan to donate blood or blood components during the study or within 1 month after the end of study.\n* Participants who experienced major trauma or had a major surgery (e.g., surgery requiring general anesthesia) within 3 months prior to screening, or those who plan to undergo a surgery (except for surgery requiring local anesthesia) during the study or within 3 months after the end of study.\n* Participants who have difficulty veins or cannot bear multiple venipunctures, or those with a history of clinically significant fear of needles or hemophobia as judged by the investigator.\n* Participants with other diseases or medical history that are clinically significant or may prevent the subjects from completing this study as judged by the investigator (including various systems such as respiratory, cardiovascular, digestive, genitourinary, hematologic, endocrine, neurological, and psychiatric systems, and malignant tumors), or other diseases or medical history that may significantly alter drug absorption, metabolism, or elimination (e.g., history of gastrointestinal surgery, renal surgery, or cholecystectomy, which may affect the in vivo disposition of the drug), or infectious diseases.\n* Participants with a history of musculoskeletal and connective tissue disorders (e.g., myalgia, myopathy) or a history of hereditary muscle diseases or rhabdomyolysis.\n\nParticipants who are not suitable for participating in this study for any other reasons as judged by the investigator.",{"count":221,"type":21},110,[127],"The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.",[225],"Bioequivalence",[227,228,225],"Fluvastatin","Pharmacokinetics","2025-02-13",{"date":231,"type":37},"2025-02-17",{"date":233,"type":21},"2025-02",{"date":235,"type":21},"2025-12",{"name":43,"class":44},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":45},"100572731","phase-2-sal-0951-in-the-treatment-of-chemotherapy-induced-anemia-in-patients-with-non-myeloid-malignancies-100572731","NCT06737081","SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies","A Parallel, Open-label Phase II Clinical Study of Enarodustat (SAL-0951) Tablets in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies","Inclusion Criteria:\n\n1. Subjects with body weight ≥40 kg at screening;\n2. Subjects with histologically or cytologically confirmed diagnosis of non-myeloid malignancy (non-curative), and planned to receive anti-tumor treatment (myelosuppressive chemotherapy) for at least 6 weeks simultaneously from the day of the first dose (Day 1);\n3. Subjects with myelosuppressive chemotherapy-related anemia, defined as central laboratory Hb ≤100 g\u002FL during the screening period, and documented decrease in Hb level ≥10 g\u002FL after the start of chemotherapy as judged by the investigator;\n4. Subjects with ferritin ≥50 ng\u002FmL and transferrin saturation (TSAT) ≥10% at screening;\n5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 at screening;\n6. Subjects with life expectancy ≥6 months as judged by the investigator on the date of first dose;\n7. All male subjects and female subjects of childbearing potential who agree to use a medically acceptable method of contraception from the day of signing the ICF until 90 days after last dose of investigational product (see section 4.3 for acceptable method of contraception);\n8. Subjects voluntary to participate in the trial, having signed the ICF, able to understand the procedures and methods of this trial and willing to strictly follow the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\n1. Subjects with tumor who are receiving myelosuppressive chemotherapy and whose expected outcome is cured;\n2. Subjects who receive hormonal agents, biologics, novel immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors) or targeted biologic therapy or radiation therapy alone to treat\u002Fcontrol their tumors. However, if chemotherapy is used in combination with these drugs, subjects can be enrolled;\n3. Subjects who have received blood transfusion therapy containing red blood cells or ESAs (including but not limited to recombinant human erythropoietin, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta\u002FCERA, pegmolesatide) within 4 weeks before the first dose of investigational product;\n4. Subjects with abnormal hepatic or renal function test results at screening as follows:\n\n   * Patients with alanine transaminase (ALT) \\>3×upper limit of normal (ULN), or aspartate transaminase (AST) \\>3×ULN, or total bilirubin (TBL) \\>1.5×ULN are not allowed to be enrolled in the study (those with TBL ≤2×ULN can be included if ALT\u002FAST is within the normal limit and the investigator believes that there is no safety concern)\n   * With estimated glomerular filtration rate (eGFR) of \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on CKD-EPI 2009scr formula, as shown in Appendix 3.\n5. Subjects with congestive heart failure (New York Heart Association \\[NYHA\\] Class III or greater), unstable angina, uncontrolled hypertension (defined as systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite antihypertensive medication), or hypertensive crisis or hypertensive encephalopathy, or a history of significant valvular or endocardial disease that would put them at risk for thromboembolism within 6 months prior to screening and\u002For within the screening period;\n6. Subjects with thromboembolic events (including but not limited to deep vein thrombosis \\[DVT\\], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack \\[TIA\\]) within 6 months prior to screening (excluding asymptomatic lacunar infarction);\n7. Subjects with clinically significant anemia caused by other causes, such as macrocytic anemia caused by vitamin B12 or folic acid deficiency, autoimmune anemia, hemolysis, genetic anemia such as sickle cell anemia or thalassemia, anemia caused by severe infection (such as active pulmonary tuberculosis, fungal infection, etc.) or existing active bleeding lesions (such as lung cancer-related hemoptysis, gastrointestinal tumor bleeding, gastrointestinal ulcer bleeding, etc.);\n8. Subjects with active systemic infection requiring chronic antibiotic therapy;\n9. Subjects with clinically significant or uncontrolled ongoing inflammatory\u002Fautoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, celiac disease, etc.);\n10. Subjects with need for an ophthalmological procedure due to diabetic eye disease, diabetic macular edema or age-related macular degeneration, or subjects with proliferative choroidal or retinal lesions;\n11. Subjects known to have significant gastrointestinal abnormalities, which would affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;\n12. Subjects known to have polycystic kidney disease;\n13. Subjects known to have serious liver disease or active liver disease (except non-alcoholic hepatic steatosis), including chronic hepatitis B (positive for hepatitis B surface antigen or hepatitis B core antibody, and HBV-DNA \\>20 IU\u002FmL), chronic hepatitis C (positive for hepatitis C antibody, and HCV-RNA quantitative detection higher than the upper limit of normal), autoimmune hepatitis, cirrhosis, or acute liver failure;\n14. Subjects tested positive for human immunodeficiency virus (HIV) antibody;\n15. Subjects with major surgery anticipated to occur during the trial;\n16. Subjects with myeloid malignancies (such as chronic myeloid leukemia, etc.);\n17. Subjects with primary or metastatic malignant tumors of the central nervous system;\n18. Subjects with anticipated use of dapsone during the trial;\n19. Subjects with hypersensitivity to HIF-PH inhibitors or any of the product components;\n20. Subjects with a history of drug or alcohol abuse in the past two years\\*;\n\n    \\*An average of 14 units of alcohol per week (1 unit ≈ 360 mL of beer, or 45 mL of liquor, or 150 mL of wine) in 2 years before screening.\n21. Subjects who have received another investigational product (or study drug), have received treatment with an investigational device (or study device), or have participated in clinical research involving intervention (medical action beyond the scope of ordinary medical practice) and received treatment during the period within 8 weeks prior to the screening;\n22. Subjects who have participated in clinical trials of HIF-PH inhibitor treatment (including enarodustat) within 4 weeks before screening and have received investigational product (active drug) treatment;\n23. Subjects who are pregnant, lactating, or may be pregnant (the possibility of pregnancy cannot be ruled out by the investigator based on the results of pregnancy test at screening visit);\n24. Subjects who have taken traditional Chinese medicine, Chinese patent medicine, and\u002For herbal medicine for anemia within 2 weeks before the first dose of investigational product;\n25. Subjects with any other medical condition that, in the opinion of the investigator, could pose a safety risk to them in this trial, could confound efficacy or safety assessment, or could interfere with their participation in the study.",{"count":125,"type":21},[24],"The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies",[248],"Anemia",[250,248,180],"Chemotherapy","2024-12-11",{"date":253,"type":37},"2024-12-17",{"date":255,"type":37},"2024-09-14",{"date":257,"type":21},"2026-06-30",{"name":43,"class":44},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":45},"100499215","evaluating-the-safety-and-efficacy-of-the-g-stream-drug-eluting-stent-in-the-above-the-knee-femoropopliteal-artery-100499215","NCT05780359","Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery","A Multicenter, Randomized, Controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Drug-eluting Peripheral Arterial Stent System（G-stream） in the Treatment of the Above-the-knee Femoropopliteal Artery Stenosis or Occlusion","G-streamPAD","Inclusion Criteria:\n\n* General Inclusion Criteria：\n\n  1. Age from 18 to 80 years, male or female;\n  2. Patients with Lower extremity peripheral artery disease (PAD);\n  3. With Rutherford classification between 2 and 5;\n  4. Patients understand the purpose of the study, voluntary participation of the study, signs the consent form, willing and able to comply with all requirements, and agrees to attend all required follow-up visits;\n* Angiographic Inclusion Criteria： 5.Single lesions or tandem lesions located in the SFA and\u002For PPA:\n\n  1. Degree of stenosis ≥ 70% and \\\u003C100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or\n  2. Occlusive lesions, total lesion length ≤ 150 mm; or\n  3. Series of lesions, total lesion length ≤ 250 mm and length of occlusive lesions ≤ 150 mm; 6.Vessel diameter ≥ 3.5 and ≤ 7.5 mm by visual angiographic assessment; 7.Re-entry device reach and cross a target lesion successfully; 8.Residual stenosis after predilation ≤ 50% without dissection characterized as type D or greater； 9. Patent homolateral iliac inflow (stenosis ≤ 50% ) or homolateral iliac inflow lesion received successfully treated i.e., residual stenosis \\\u003C 30% after treatment, without severe flow-limiting dissection characterized as type D or greater, without thrombosis, embolism or other serious adverse events; 10.Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (stenosis ≤ 50%) to the ankle or foot before procedure or with planned intervention.\n\nExclusion Criteria:\n\n-General Exclusion Criteria：\n\n1. Wtih vasculitis or Berger disease;\n2. With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;\n3. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;\n4. History of distal amputation (above the metatarsal) in the target limb or contralateral limb;\n5. Severe renal insufficiency (creatinine \\> 221 umol\u002FL);\n6. History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;\n7. History of acute myocardial infarction within 30 days prior to procedure;\n8. History of major surgery（i.e., open cardiac operation, open abdominal surgery or open operation for peripheral artery disease) within 30 days prior to procedure;\n9. History of alimentary tract hemorrhage within 3 months prior to procedure;\n10. History of stroke\u002Fcerebrovascular accident (CVA) within 6 months prior to procedure;\n11. Life expectancy \\\u003C12 months;\n12. History of stent, drug-coated balloon or bypass surgery in the target lesion;\n13. Use of atherectomy, laser, cryoplasty or other debulking devices in the target lesion during the index procedure;\n14. Pregnant, breast feeding, or plan to become pregnant;\n15. Current participation in another investigational drug or device clinical study;\n16. According to the judgement of the investigator, other situations that are not suitable for enrollment;\n\n    * Angiographic Exclusion Criteria:\n17. Heavily calcified lesions;\n18. Presence of aneurysm in the target vessel;\n19. Acute or subacute thrombosis of the target vessel;\n20. History of graft intervention in the target limb.",{"count":268,"type":21},280,[270],"NA","A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system（G-stream） in the treatment of femoropopliteal artery stenosis or occlusion.",[273],"Peripheral Artery Disease",[275,276,273],"drug eluting stent","drug coating ballon","2023-03-20",{"date":279,"type":37},"2023-03-22",{"date":281,"type":37},"2022-05-27",{"date":283,"type":21},"2026-08-31",{"name":43,"class":44},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":45},"100431291","sirolimus-deb-in-coronary-bifurcation-lesions-100431291","NCT04896177","Sirolimus DEB in Coronary Bifurcation Lesions","A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions","Inclusion Criteria:\n\n1. Male or Female that ages 18-85 year old;\n2. Having evidence of myocardial ischemia;\n3. Voluntarily participates in this study and signs the informed consent form (ICF);\n4. Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;\n5. Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;\n6. Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;\n7. Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;\n8. The target vessel diameter was 2.0mm-4.0mm.\n\nExclusion Criteria:\n\n1. Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;\n2. Cardiogenic shock patients;\n3. With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;\n4. ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;\n5. With severe congestive heart failure or NYHA class Ⅳ heart failure;\n6. With severe valvuar heart disease;\n7. Heart transplant patients;\n8. With renal insufficiency (creatinine \\> 3.0mg\u002F dL or 265.2 umol \u002FL) and\u002For advanced renal disease requiring dialysis;\n9. With a life expectancy less than 1 year;\n10. With contraindications who cannot take aspirin and\u002For clopidogrel and\u002For ticagrelor;\n11. With known allergies to paclitaxel, sirolimus, contrast agents, etc.;\n12. Participating in clinical trials of other drugs or devices and has not met the primary endpoint;\n13. Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;\n14. Intra-stent restenosis;\n15. High-risk left main disease;\n16. Other patients considered by the investigator to be unsuitable for inclusion.","85 Years",{"count":268,"type":21},[270],"The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.\n\nThis is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.",[297],"Coronary Bifurcation Lesions",[299,300,301,302],"drug-eluting balloon","coronary bifurcation lesions","coronary heart disease","sirolimus","2021-05-20",{"date":305,"type":37},"2021-05-21",{"date":307,"type":37},"2021-03-18",{"date":309,"type":21},"2026-09-18",{"name":43,"class":44},""]