[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ganzhou Hemay Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":180},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,66,87,113,135,157],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642782","phase-3-hemay005-for-the-treatment-of-chinese-moderately-to-severely-active-ulcerative-colitis-100642782",false,"NCT07650942","Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Re-randomized Study To Assess the Efficacy and Safety With Hemay005 Tablets in Chinese Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Men or women 18 to 80 years of age, inclusive, at the time of consent.\n2. Voluntarily to give written informed consent.\n3. Diagnosed with UC established at least 3 months prior to screen visit. The diagnosis must be confirmed by clinical and endoscopic evidence, corroborated by a histopathology report.\n4. Active UC confirmed by endoscopy, classified as Montreal E2 or E3.\n5. Moderately to severely active UC, defined as mMS of 5 to 9 points, including a MES of at least 2 (confirmed through centrally read endoscopy) and a SFS of at least 1 and a RBS of at least 1. The endoscopy should be performed within 14 days prior to randomization.\n6. Demonstrated inadequate response, loss of response and\u002For intolerance to at least one of the following UC therapies:\n\n   A) Conventional therapies, including oral 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunoregulatory agents.\n\n   B) Advanced therapies: biologics (including but not limit to antitumor necrosis factor alpha (TNFα) antibodies, anti-integrin antibodies, anti-interleukin 12\u002F23 antibodies) and small molecule therapies(including but not limit to JAK inhibitors, S1P receptor modulators) Note: The medication used to qualify the subject for entry into this category must be approved for the treatment of UC in the country of use and the subject must have received an adequate course of therapy based on local guidelines for that therapy.\n7. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception and agreement to refrain from egg donation or undergo fertility treatment during the treatment period and for 30 days after the final dose of Hemay005. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 30 days after the final dose of Hemay005.\n\nExclusion Criteria:\n\n1. Current diagnosis of CD, abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n2. Severe UC as evidenced by any of the following:\n\n   A) Hospitalization for the treatment of UC ≤ 2 weeks prior to screening or, in the physician's judgement, is likely to require hospitalization for medical care or surgical intervention of any kind for UC during the study.\n\n   B）Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months) of toxic megacolon, or bowel perforation.\n\n   C）Prior history of subtotal, or total colectomy.\n3. Past or current evidence of any gastrointestinal malignancy, either prior to or at the time of screening. History of malignancy within 5 years prior to screening visit, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.\n4. Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.\n5. Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, ), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures.\n6. Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).\n7. Evidence of active tuberculosis (TB).\n8. Any condition that would preclude endoscopic evaluation.\n9. Either received protocol-specified prohibited medicines prior to baseline endoscopy and\u002F or randomization, or have not be washed out sufficiently due to the protocol before baseline endoscopy and\u002F or randomization.","ALL","18 Years","80 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with moderately to severely active ulcerative colitis.",[27],"Ulcerative Colitis (UC)",[29],"Inflammatory Bowel Disease","NOT_YET_RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-16","ACTUAL",{"date":36,"type":21},"2026-06",{"date":38,"type":21},"2029-02",{"name":40,"class":41},"Ganzhou Hemay Pharmaceutical Co., Ltd","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100640733","phase-1-a-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-hemay5087-in-patients-with-advanced-solid-tumors-100640733","NCT07624864","A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors","A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS","Inclusion Criteria:\n\n1. Subjects who voluntarily signed a written informed consent form before the start of the study;\n2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .\n3. Subjects who have a least one measurable lesion that can be evaluated by CT\u002FMRI and meets the requirement for reproducible evaluation in RECIST V1.1;\n4. At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and\u002For major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0) \\[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\\];\n5. Subjects with ECOG PS score of 0-1;\n6. Subjects with expected survival more than 3 months;\n7. Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;\n\nExclusion Criteria:\n\n1. Women during pregnancy or breastfeeding;\n2. Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA \\> ULN;;\n3. Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;\n4. Aallergy to the active ingredient or excipients of the investigational medicinal product;\n5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;\n6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.","75 Years",{"count":52,"type":21},24,[54],"PHASE1","An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.",[57],"Solid Tumors","2026-05-29",{"date":60,"type":34},"2026-06-03",{"date":62,"type":21},"2026-07-15",{"date":64,"type":21},"2028-06-30",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":55,"conditions":75,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100627298","phase-1-a-clinical-study-evaluating-the-preliminary-anti-tumor-efficacy-and-safety-of-hemay181-100627298","NCT07446816","A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181","A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Subjects who voluntarily signed a written informed consent form before the start of the study;\n2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .\n3. Subjects who have a least one measurable lesion that can be evaluated by CT\u002FMRI and meets the requirement for reproducible evaluation in RECIST V1.1;\n4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and\u002For major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \\[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\\].\n5. Subjects with ECOG PS score of 0-1;\n6. Subjects with expected survival more than 3 months;\n7. Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study;\n\nExclusion Criteria:\n\n1. Women during pregnancy or breastfeeding;\n2. HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;\n3. Having received drug treatment from another clinical trial within the four weeks prior to enrolment;\n4. Aallergy to the active ingredient or excipients of the investigational medicinal product;\n5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;\n6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.",{"count":52,"type":21},[54],[76],"Advanced Solid Tumors","RECRUITING","2026-02-25",{"date":80,"type":34},"2026-03-03",{"date":82,"type":34},"2025-12-03",{"date":84,"type":21},"2027-08",{"name":40,"class":41},1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":42},"100617101","phase-2-a-study-to-investigate-the-biomarkers-of-hemay005-in-adult-participants-with-moderate-to-severe-copd-100617101","NCT07314242","A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD","A Randomized, Double-blind, Single-dummy, Positive Drug and Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Age at least 40 years old at the time of signing the informed consent form, both gender;\n2. Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and\u002For with chronic productive cough at least 12 months prior to screening;\n3. Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)\u002FFVC (forced vital capacity) ratio\\\u003C70% after albuterol use, and FEV1 after albuterol use\\>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;\n4. Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).\n5. At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).\n6. Subjects voluntarily participate in this clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with a prior history of asthma or concurrent diagnosis of asthma, with or without active disease, are excluded.\n2. Subjects with a moderate or severe COPD exacerbation i.e. resulting in the use of systemic corticosteroids (oral\u002FIV\u002FIM corticosteroids) and\u002For antibiotics or need for hospitalisation or a lower respiratory tract infection 6 weeks prior to screening.\n3. Diseases that in the opinion of the investigator may interfere with clinical assessments, such as bronchiectasis, sarcoidosis, cystic fibrosis, pulmonary hypertension, interstitial lung disease, bronchiolitis, pneumonectomy, lung cancer, congestive heart failure, diffuse bronchiolitis, silicosis, etc.\n4. COPD with emphysema phenotype according to the investigator's judgment and\u002For medical history records (emphysema phenotype is defined as alveolar destruction leading to permanent airway obstruction, in addition to cough and sputum, subjects usually have severe symptoms of dyspnea, shortness of breath, etc.); or have alpha1-antitrypsin deficiency.\n5. Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive).\n6. . The investigator judged that the patient had other conditions that were not suitable for entry into this study.","40 Years",{"count":96,"type":21},120,[98],"PHASE2","A Multicenter, Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).",[101],"COPD (Chronic Obstructive Pulmonary Disease)",[103,104],"COPD","biomarkers","2025-12-18",{"date":107,"type":34},"2026-01-02",{"date":109,"type":21},"2026-01-01",{"date":111,"type":21},"2027-12-31",{"name":40,"class":41},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":86},"100545021","phase-1-to-evaluate-the-pharmacokinetics-of-hemay005-tablets-in-subjects-with-liver-damage-100545021","NCT06376474","To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage","To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild, Moderate Liver Impairment and Normal Liver Function After a Single Oral Administration","Inclusion Criteria:\n\n* 1\\. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;\n\n  2\\. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);\n\n  3\\. The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) : 19-32 kg\u002Fm2 (including cut-off value);\n\n  4\\. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least 28 days (or up to 14 days for patients with moderate liver function) before taking the study drug) due to primary liver disease (e.g., autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc.); Patients were classified as grade A\u002Fmild (Child-Pugh score: 5-6) or grade B\u002Fmoderate (Child-Pugh score: 7-9) according to the Child-Pugh classification within 72 hours before taking the study drug; Among them, the researchers used standard diagnosis and treatment methods, combined with the patient's past medical history, laboratory tests, liver biopsy or imaging examination and other documents to diagnose chronic liver function impairment, and then evaluated according to the Child-Pugh classification.\n\n  5\\. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant diseases for at least 28 days (or 14 days for patients with moderate liver function) before taking the study drug, and who do not need to adjust the medication (including the type, dose, or frequency of medication); Or those who do not use drugs;\n\n  6.In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.\n\nExclusion Criteria:\n\n* 1\\. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other malignant tumors; Patients with hepatorenal syndrome; Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion; Patients with complications such as hepatic encephalopathy (according to Child-Pugh criteria), liver failure, esophageal and gastric varices bleeding, severe\u002Fadvanced ascites or pleural effusion requiring puncture drainage and albumin supplementation, who were considered by the investigator to be unsuitable;\n\n  2\\. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs within 1 year before screening, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immune and other diseases, judged by the investigator to be not suitable for the trial;\n\n  3\\. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), Unstable angina pectoris, coronary artery\u002Fperipheral artery bypass grafting, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism;\n\n  4\\. (asking) a history of depression or suicidal tendencies;\n\n  5\\. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery within 3 months before screening, and the investigators thought that the absorption of drugs was affected;\n\n  6\\. (Inquiry) patients who lost blood or donated more than 400mL of blood within one month before screening, or received red blood cell transfusion;\n\n  7\\. (Inquiry) Liver function fluctuation (e.g., active hepatitis), rapid deterioration (e.g., advanced ascites, fever, active gastrointestinal bleeding), CTCAE 5.0 common adverse event grade ≥ 2, ongoing arrhythmia, atrial fibrillation of any grade during screening;\n\n  8.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \\>5 times the normal value; (b) neutrophil count \\\u003C1.0×109\u002FL; (c) hemoglobin (HGB) \\\u003C90 g\u002FL; (d) platelet level \\\u003C50×109\u002FL; (e) subjects with alpha-fetoprotein (AFP) \\>50 ng\u002FmL and suspected hepatocellular carcinoma;\n\n  9\\. (Inquiry) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic condition (such as allergic to two or more drugs, foods or pollens), or known allergic to PDE4 inhibitors (such as apast, roflumilast, etc.);\n\n  10\\. (inquiry) those who had a history of drug abuse in the past 5 years or drug abuse in the past 3 years before screening;\n\n  11\\. Screen-positive for drug abuse (except those screen-positive for drug abuse due to concomitant medication);\n\n  12\\. Positive breath alcohol test (alcohol concentration \\>0mg\u002FL);\n\n  13\\. (Inquiry) who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mL of 40% liquor or 147 mL of 12% wine), or who could not abstain from alcohol during the study;\n\n  14\\. (Inquiry) who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study;\n\n  15\\. (Inquiry) subjects who consumed excessive amounts of tea, coffee and\u002For caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) per day in the previous 3 months;\n\n  16\\. Having one or more of the tests for hepatitis B, C, HIV and syphilis clinically significant;\n\n  17\\. (Inquiry) who participated in clinical trials of other drugs\u002Fdevices within 3 months before screening and used the trial drugs\u002Fdevices;\n\n  18\\. (Inquiry) who had received drugs with definite potential hepatotoxicity (such as acetaminophen, statins, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, rifampicin, etc.) for 7 consecutive days or more within 3 months before screening;\n\n  19\\. (Inquiry) Use of any drugs (e.g., inductors-barbiturates, pioglitazone, carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepatic drug-metabolizing enzymes within 30 days before screening; Inhibitors: SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, isoniazid);\n\n  20\\. (Inquiry) who used prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines other than those used for liver function impairment and other concomitant diseases within 2 weeks before screening;\n\n  21\\. (Inquiry) any caffeine\u002Fxanthine\u002Ffood or drink (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine\u002Fxanthine\u002Fmay affect the absorption, distribution, metabolism, excretion of drug in the judgment of the investigator during the period from screening to day -1 of admission, or unable to stop the intake of the above food or drink during the trial;\n\n  22\\. (Asking) pregnant or lactating women, or subjects (including male subjects) who have plans to give birth or donate sperm or eggs from two weeks before the trial to six months after the last dose of drug, unwilling or not to take effective contraceptive measures;\n\n  23\\. (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and\u002For cannot follow a uniform diet;\n\n  24\\. (inquiry) with a history of epileptic seizures;\n\n  25\\. (Inquiry) Those who cannot tolerate venipuncture and\u002For have a history of dizzy with blood and needles;\n\n  26\\. Subjects with other factors considered by the investigator to be ineligible for the trial.",true,"70 Years",{"count":52,"type":21},[54],"The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.",[126],"Psoriasis","2025-12-02",{"date":129,"type":34},"2025-12-04",{"date":131,"type":34},"2024-04-28",{"date":133,"type":21},"2025-12-31",{"name":40,"class":41},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":86},"100496837","phase-1-a-phase-i-study-of-hemay181-in-patients-with-advanced-solid-tumors-100496837","NCT05749432","A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Antitumor Efficacy of Hemay181 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged 18 to 65 years;\n2. Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;\n3. Advanced solid tumors patients that confirmed by pathology (histology or cytology) with adequate standard therapy failure or currently have no effective standard treatment (such as breast, liver, lung, gastric cancer, colorectal cancer, etc.); Standard therapy failure is defined as: patients who have undergone at least 2 lines of standard antineoplastic therapy after recurrence\u002Fmetastasis (including treatment-naïve stage IV) (if only 1-line therapy is recommended for the tumor, standard 1-line therapy shall prevail), and who have been confirmed by the investigator or have a clear disease progression or are intolerable by the medical history;\n4. At least one lesion that can be evaluated by CT\u002FMRI (measurable lesions are required) and meet the reproducible evaluation requirements in RECIST V1.1;\n5. At least 4 weeks after the latest treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and\u002For major surgery, etc.), at least 2 weeks after endocrine therapy, and have recovered from the toxic effects caused by previous treatment to lower than grade 1 (CTCAE version 5.0) \\[patients with hair loss (any grade), pigmentation (any grade), peripheral sensory neuropathy (grade ≤2) can be enrolled\\];\n6. Eastern Cooperative Oncology Group(ECOG) score of 0,1；\n7. Life expectancy of at least three months;\n8. Adequate bone marrow, liver, kidney function, meeting the following criteria:\n\n   ANC≥1.5×10\\^9\u002FL, HB≥90g\u002FL, PLT≥75×10\\^9\u002FL; ALT≤2.5×ULN, AST≤2.5×ULN with no liver metastasis, or ALT≤5×ULN, AST≤5×ULN with liver metastasis; TBIL≤1.5×ULN; Serum creatinine ≤1.5×ULN；\n9. All female and male subjects must agree and commit to the use of a reliable contraceptive regimen for the duration of the study and for at least 12 weeks after at the last dose of test article.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Patients with known central nervous system metastatic disease;\n3. Positive blood for human immunodeficiency virus (HIV antibody); Positive hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (HBV-DNA)\\>upper limit of normal; Active hepatitis C virus (HCV) infection;\n4. Patients with active infection requiring intravenous anti-infective therapy;\n5. Patients with a history of irinotecan allergic reactions or previous irinotecan gastrointestinal toxicity ≥ grade 3;\n6. Have received drug therapy from other clinical trials within 4 weeks prior to enrollment;\n7. Known allergy to the active ingredient or excipients of the test drug;\n8. The investigator believes that the subject has any clinical or laboratory abnormalities and is not suitable to participate in this clinical study.","65 Years",{"count":144,"type":21},51,[54],"The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors.",[148],"Solid Tumor","2025-04-17",{"date":151,"type":34},"2025-04-18",{"date":153,"type":34},"2023-03-20",{"date":155,"type":21},"2026-07-31",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100527294","phase-3-a-study-of-efficacy-and-safety-of-hemay005-tablets-in-patients-with-behets-disease-100527294","NCT06145893","A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease","A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease","Inclusion Criteria:\n\n1. Understanding and voluntarily signing the Informed Consent Form (ICF) for this study;\n2. Age 18-75 years (inclusive), male or female;\n3. Diagnosed as BD based on the ICBD-2013;\n4. At least 2 oral ulcers present at V1 (screening), and:\n\n   1. at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR\n   2. at least 3 oral ulcers present at V2 (the day of randomization) when V2 occurs 0-13 days after V1;\n5. Applicability of systemic treatment for oral ulcers: Based on the severity of the disease and the involved area, the investigator determines that the patient's oral ulceration is not suitable for topical treatment or that the patient's oral ulceration cannot be effectively controlled by topical treatment, so that systemic treatment is to be used;\n6. Throughout the study period from signing of ICF through 3 months after the last study dose, women of childbearing potential and male subjects who have not undergone vasoligation should use effective contraceptive measures, including vasoligation, abstinence, intrauterine device (IUD), hormones (oral, patches, rings, injections, implants) and barrier methods (diaphragms, cervical caps, sponges, condoms);\n7. Being able to comply with the follow-up schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Active lesions associated with BD in major organs requiring immunosuppressive treatment, e.g., those in lungs (e.g., pulmonary aneurysm), blood vessels (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal tract (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis); Note: Patients with refractory BD who experienced gastrointestinal perforation, active bleeding, or obstruction, etc. within 3 months prior to randomization are to be excluded.\n2. Any clinically significant heart disease (including but not limited to: unstable ischemic heart disease, NYHA III\u002FIV left ventricular failure, or myocardial infarction) or clinically significant 12-lead ECG abnormalities detected during the 6 months prior to screening, which, at the investigator's discretion, may put the subject at safety risk or may interfere with the study assessments;\n3. Use of the following immunomodulatory therapies:\n\n   * Colchicine within 7 days prior to randomization;\n   * Perazathioprine, mycophenolate, baritinib, or tofacitinib within 10 days prior to randomization;\n   * Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone within 4 weeks (28 days) prior to randomization;\n   * Biologics within 5 half-lives prior to randomization, e.g.:\n\n     * Etanercept within 4 weeks prior to randomization;\n     * Infliximab or leflunomide within 8 weeks prior to randomization;\n     * Adalimumab, golimumab, abatacept, or tolizumab within 10 weeks prior to randomization;\n     * Secukinumab within 6 months prior to randomization;\n4. Intraarticular or systemic corticosteroid treatment prior to randomization and within 5 pharmacokinetic\u002Fpharmacodynamic half-lives; Note: For subjects with eye symptoms, glucocorticoid eye drops are allowed throughout the trial (except for within 24 hours prior to a trial visit).\n5. Chinese patent medicines with immunomodulatory effect within 2 weeks prior to randomization; any Chinese pate nt medicines or decoctions within 2 weeks prior to randomization that might affect efficacy evaluation, or containing sinomenine, total glucoside of paeony, or tripterygium wilfordii, etc.;\n6. Laboratory tests:\n\n   * Hemoglobin ≤85g\u002FL;\n   * White blood cell count \\\u003C3.0×10\\^9\u002FL or \\>14×10\\^9\u002FL;\n   * Platelets \\\u003C100×10\\^9\u002FL;\n   * Serum creatinine \\>1.5 mg\u002FdL (\\>132.6 μmol\u002FL);\n   * Total bilirubin of \\>2.0 mg\u002FdL (\\>34.2 μmol\u002FL);\n   * Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥1.5×ULN; Note: The above tests can be repeated at most once during the screening period. If the result within 2 weeks prior to randomization falls into the specified range, the subject is eligible for the study;\n7. Use of potent inducers of cytochrome P450 enzymes (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin sodium) within 4 weeks prior to randomization;\n8. Other autoimmune diseases or chronic inflammatory diseases associated with immunity, e.g., rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, multiple sclerosis, Sjögren's syndrome, and inflammatory bowel disease;\n9. Currently active infections or recurrent bacterial, fungal, viral, mycobacterial or other infectious diseases (including but not limited to tuberculosis, atypical mycobacteriosis, hepatitis B, hepatitis C, herpes zoster, histoplasmosis, and coccidiosis; however, onychomycosis is excluded), which, at the investigator's discretion, may put the subject at safety risk; Note: Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or with a history of active mycobacterial infection of any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit should be excluded. Screening is permitted if the subject has been cured for at least 3 years prior to randomization with documentation available for verification;\n10. Clinically significant chest X-ray or CT abnormalities, which, at the investigator's discretion, may put the subject at safety risk; Note: If a chest X-ray or CT was performed within 3 months prior to V1, the examination may be omitted for V1;\n11. History of transplantation or immunodeficiency;\n12. Positive for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody test;\n13. Currently having a malignant tumor, or a history of any malignant tumor within 5 years prior to screening (except for treatment-experienced squamous cell carcinoma in situ of the skin, basal cell carcinoma or cervical carcinoma in situ with no evidence of relapse within the past 12 months);\n14. Use of any clinical investigational product within 4 weeks prior to randomization or 5 pharmacokinetic\u002Fpharmacodynamic half-lives, whichever is longer; Note: Subjects who have participated in HM005BD2S01 study are not eligible to participate in this trial;\n15. Known allergy to the study drug or any of its components or allergic constitution;\n16. A history of alcohol or drug abuse or dependence, or psychiatric disorder;\n17. Any conditions that may interfere with oral drug absorption, e.g., subtotal gastrectomy, clinically significant diabetic gastrointestinal disease, or certain types of bariatric surgery such as gastric bypass surgery, not including procedures that simply separate the stomach into separate chambers such as gastric banding surgery;\n18. Prior use of apremilast;\n19. Female subjects who are pregnant or breast feeding;\n20. Concomitant serious, progressive, or uncontrolled diseases, with which participation in the study may, at the investigator's discretion, put the subject at potential risk or affect the interpretation of study results.",{"count":165,"type":21},162,[24],"This is a phase 3, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups. After subject randomization, each subject will enter an core-treatment Phase for 12 weeks following an extended-treatment phase for another 40 weeks and a follow up phase for 4weeks.",[169],"Behçet's Disease",[169],"2025-04-06",{"date":173,"type":34},"2025-04-08",{"date":175,"type":34},"2023-11-13",{"date":177,"type":21},"2026-06-30",{"name":40,"class":41},22,""]