[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Changchun Intellicrown Pharmaceutical Co. LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,68],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100594222","phase-1-to-evaluate-the-tolerability-pharmacokinetics-and-pharmacodynamics-of-imm-h014-in-patients-with-mash-100594222",false,"NCT07016633","To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH","A Phase Ib\u002FIIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 Consecutive Multiple Treatment for 12 Weeks in Adult Patients With MASH","Inclusion Criteria:\n\n1. Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment;\n2. Voluntarily comply with the experimental requirements and conduct follow-up visits on designated dates, demonstrating good adherence to the protocol; And voluntarily maintain the original lifestyle (diet and exercise habits) during the study period without changing.\n3. Participants (including partners) agree to take effective contraceptive measures throughout the study period until 6 months after discontinuation of medication;\n4. Male and female patients aged 18 to 65 years old (including 18 and 65 years old);\n5. If suffering from hypertension, blood pressure should be stabilized at 160\u002F100mmHg or below under monotherapy control;\n6. If the patient has type 2 diabetes, the patient must have not taken any medicine, or has received metformin, sulfonylurea or α - glycosidase inhibitor treatment, and the dose should be stable for at least 3 months;\n7. The presence of hepatic steatosis accompanied by at least one of the following cardiovascular metabolic risk factors (guidelines for the prevention and treatment of metabolism related (non-alcoholic) fatty liver disease 2024).\n\n   BMI ≥ 24.0 kg\u002Fm2, or waist circumference ≥ 90cm (male) and 85cm (female), or excessive body fat content and percentage.\n\n   Arterial blood pressure ≥ 130\u002F85 mmHg, or under treatment with antihypertensive drugs.\n\n   Fasting blood glucose ≥ 6 1mmol \u002FL, Or blood glucose level ≥ 7 2 hours after glucose load 8 mmol\u002FL or HbA1c ≥ 5.7%, or history of type 2 diabetes, or HOMA-IR ≥ 2.5.\n\n   Fasting serum TG ≥ 1.70 mmol\u002FL, or currently receiving lipid-lowering medication treatment.\n\n   Serum high-density lipoprotein ≤ 1 0 mmol\u002FL (male) and 1 3 mmol\u002FL (female), or currently being treated with lipid-lowering drugs.\n8. Screening period ALT ≥ ULN. Or histological evidence of NASH (NAS score ≥ 4, with inflammation and ballooning at least 1 point each, fibrosis level ≤ F3, scoring criteria in Appendix 6) obtained through liver pathological biopsy within the 6 months prior to screening or during the screening period, and no treatment or weight loss within 6 months (weight change\\\u003C5% within 6 months);\n9. MRI-PDFF ≥ 10% within 28 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Excessive alcohol consumption for three consecutive months or more within the year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, 25 mL of spirits, or 100 mL of wine);\n2. Individuals with allergies (to multiple drugs or foods);\n3. Donate blood or experience significant blood loss (\\>450 mL) within the first three months of screening;\n4. Individuals with a history of weight loss surgery or those who are planning to undergo weight loss surgery recently;\n5. History of liver transplantation surgery or planned liver transplantation;\n6. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;\n7. Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis;\n8. Patients with type 1 diabetes;\n9. Uncontrolled type 2 diabetes patients (HbA1c ≥ 8.0%);\n10. Other clinically significant diseases (including but not limited to respiratory system, circulatory system, digestive system, endocrine system, rheumatic and immune system, nervous system, hematological system diseases, and psychiatric\u002Fpsychological diseases) that are found to be unstable or untreated before screening;\n11. History of swallowing difficulties or any gastrointestinal diseases or surgeries that affect drug absorption;\n12. Existence of any of the following diseases or medical histories: unstable angina, myocardial infarction, percutaneous coronary intervention (allowing diagnostic angiography), coronary artery bypass surgery, heart failure, transient ischemic attack, cerebrovascular accident, etc;\n13. Currently taking medications that may cause steatosis\u002Fsteatohepatitis (including amiodarone, methotrexate, steroid hormones, tetracycline, tamoxifen, valproic acid, etc.);\n14. Newly taken or irregularly taken hypoglycemic drugs (excluding metformin, sulfonylureas, or alpha glucosidase inhibitors), hepatoprotective drugs (including but not limited to reduced glutathione, glucuronide, glycyrrhetinic acid preparations, ursodeoxycholic acid, niacinamide, biphenyl diesters, liver protection tablets, silibinin, etc.), and lipid-lowering drugs (including but not limited to fibrates, statins, niacin, colexamine, etc.) within 90 days before enrollment;\n15. Currently receiving treatment with anti TNF - α drugs such as adalimumab, etanercept, etc;\n16. 28 days prior to screening or during the study period, any drugs that alter liver enzyme activity CYP3A4, including strong inhibitors and inducers that affect liver metabolic enzymes, are planned to be taken concurrently;\n17. Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks prior to enrollment;\n18. Individuals who have participated in clinical trials of other drugs within 3 months prior to medication use;\n19. Abnormal electrocardiogram with clinical significance, QTcF\\>450ms;\n20. Suspected liver and gallbladder diseases with other causes based on medical history and laboratory tests, including but not limited to: hepatitis B or C virus infection, chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's liver disease, alpha and alpha antitrypsin deficiency, liver cancer, significant liver dysfunction (ALT or AST ≥ 5 × ULN or TBIL ≥ 1.5 × ULN), etc;\n21. Positive for HIV infection;\n22. Kidney disease or renal dysfunction with clinical significance, blood creatinine\\>1.5 × ULN, eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2 \\[calculation formula: eGFR=186 × Scr-1.154 × Age-0.203 × (0.742 female)\\], etc;\n23. Platelet count\\\u003C100 × 109\u002FL;\n24. Confirmation of positive and clinically significant anti nuclear antibody (ANA);\n25. TSH abnormality with clinical significance;\n26. Pregnant and lactating women or those with positive serum pregnancy tests;\n27. Patients with contraindications to MRI scanning;\n28. Have taken any alcoholic products within 24 hours prior to taking the study medication;\n29. Consumed chocolate, any caffeinated or xanthine rich food or beverage 24 hours prior to taking the study drug;\n30. Acute illness occurs from the screening stage to the study medication;\n31. Individuals who have tested positive in urine drug screening or have a history of drug abuse or use of drugs within the past five years.","ALL","18 Years","65 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.",[28],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","NOT_YET_RECRUITING","2025-06-10",{"date":32,"type":33},"2025-06-13","ACTUAL",{"date":30,"type":21},{"date":36,"type":21},"2027-12-01",{"name":38,"class":39},"Changchun Intellicrown Pharmaceutical Co. LTD","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100394173","phase-1-zz06-in-adult-patients-with-advanced-solid-tumor-malignancies-100394173","NCT04412616","ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies","A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed advanced solid tumor that is positive for EGFR and has progressed despite standard therapy or for whom no standard therapy exists.\n* Patients are required to have archival tumor tissue available for assessment of EGFR status via FDA-approved EGFR assay .\n* Age ≥ 18 years.\n* Patients must have at least 1 measurable lesion as defined by RECIST v1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Baseline organ function and laboratory data meet the following criteria:\n\n  1. Bone marrow： ANC ≥ 1500 cells\u002Fmm3； Platelet count ≥ 75 000 cells\u002Fmm3； Hemoglobin ≥ 8.0 g\u002FdL.\n  2. Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤ 1.5× ULN；\n  3. Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration rate≥ 60 mL\u002Fmin (Cockcroft-Gault formula).\n  4. Hepatic function： Serum total bilirubin ≤ 1.5 mg\u002FdL； AST and ALT ≤ 3.0× ULN (if metastases are present, ≤ 5.0× ULN).\n* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.Patients must provide written informed consent prior to any study procedures.\n\nExclusion Criteria:\n\n* History of another primary cancer ≤ 3 years, with the exception of completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix.\n* Active or symptomatic CNS metastases. Patients with treated CNS metastases that have been stable for ≥ 4 weeks and do not require treatment with steroids or anticonvulsants may be enrolled at the discretion of the Investigator.\n* Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency virus infection.\n* Active, clinically significant infections.\n* Clinically significant cardiovascular disease, including any of the following:\n\n  1. Congestive heart failure (New York Heart Association Class \\> 2).\n  2. Serious cardiac arrhythmia.\n  3. Myocardial infarction ≤ 6 months.\n  4. Unstable angina.\n* Prior clinically significant allergic reaction to chimerized or murine monoclonal antibody therapy.\n* Prior treatment ≤ 6 months with cetuximab, panitumomab, gefitinb, erlotinib, or other therapy that specifically and directly targets the EGF pathway.\n* Anticancer therapy or investigational agents for nonmalignant disease ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1, with the exception of tamoxifen for patients with a history of operated breast cancer \\> 3 years and no evidence of disease after surgery.\n* Major surgery ≤ 4 weeks.\n* Clinically significant psychiatric illness, other comorbidity, or laboratory abnormality that, in the opinion of the Investigator, makes it unsafe for the patient to participate in the study or may interfere with study compliance or study results.\n* Other unspecified reasons that, in the opinion of the Investigator, make the patient unsuitable for enrollment.",{"count":49,"type":21},60,[24],"This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.",[53],"Advanced EGFR Positive Solid Tumor",[55,56,57,58],"treatment-emergent adverse event (TEAE)","dose limiting toxicity (DLT)","pharmacokinetic (PK)","antidrug antibodies (ADA)","RECRUITING","2025-06-05",{"date":30,"type":33},{"date":63,"type":33},"2020-09-01",{"date":65,"type":21},"2026-07-06",{"name":38,"class":39},5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100532687","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-and-food-effects-of-imm-h014-in-healthy-subjects-100532687","NCT06216041","To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects","A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMM-H014 Sand the Effects of Food on Pharmacokinetics in Healthy Subjects","Inclusion Criteria:\n\n1. Subjects can voluntarily participate in the clinical trial, sign informed consent before the trial, fully understand the trial content, process and possible adverse events, and complete the study in accordance with the requirements of the trial protocol;\n2. Subjects can use effective contraceptive methods, such as abstinence, condoms, IUD use, and dual barrier method (such as condom plus diaphragm), within 6 months from the beginning of screening to the last trial drug administration;\n3. 18-45 years of age, male and female (including 18 and 45 years);\n4. Male weight ≥50kg, female weight ≥45kg; Body mass index (BMI) in the range of 18-28 kg\u002Fm2 (including the cut-off value); 5）Vital signs and physical examination with normal or abnormal has no clinical significance.\n\nExclusion Criteria:\n\n1. Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and related excipients;\n2. Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 2 weeks before screening;\n3. Clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, virology examination, thyroid function), abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, kidneys, adrenal gland), chest radiography and other abnormalities with clinical significance; Or other clinically significant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) within 6 months before screening;\n4. Subjects who ate diets (including grapefruit or grapefruit products, pitaya, mango, etc.) that may affect drug metabolism within 7 days before screening, or had strenuous exercise, or the researchers thought that there were other dieters that affected drug metabolism, absorption, distribution, metabolism and excretion;\n5. A family history of a first-degree relative (i.e., biological parent, sibling, or child) with a risk factor for tip torsional ventricular tachycardia, or a family history of short QT syndrome, long QT syndrome, sudden unexplained death in youth (less than\u002Fetc. 40 years old), or sudden infant death syndrome;\n6. Subjects who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically significant by the investigator;\n7. Presence of clinically significant abnormalities in ECG or QTcF\\>450ms (corrected according to Frederica formula, the calculation method is QTCF = Qt\u002F(RR 0.33));\n8. Creatinine clearance rate \\\u003C 90mL\u002Fmin (Creatinine clearance calculation Cockcroft-Gault formula: CrCl = \\[(140 - age) by weight (kg)\\] \u002F \\[0.814 x Scr (umol\u002FL)\\] or CrCl = (140 - age) by weight (kg) \u002F 72 x Scr (mg\u002FdL), women need to according to the formula calculation results by 0.85);\n9. Suffering from chronic or active gastrointestinal diseases, such as esophageal diseases, acute gastritis, gastric and duodenal ulcers, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, which investigators believe is still clinically relevant;\n10. Subjects who had undergone major surgery (excluding diagnostic surgery) in the six months prior to screening, or who will undergo surgery during the study period, or who had undergone surgery that the investigator determines will affect drug absorption, distribution, metabolism, or excretion;\n11. Participants who had participated in other clinical trials within 3 months prior to screening (participants can be enrolled if they withdraw from the study before administration of the investigational drug, that is, they have not received the drug);\n12. Blood donation or significant blood loss (\\> 450ml) within 3 months prior to screening;\n13. Had a history of alcohol abuse (drinking an average of 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer or 45mL liquor with 40% alcohol or 150 ml wine), or could not abstinence during the test period, or had a positive alcohol breath test;\n14. Smoking more than 5 cigarettes per day in the 3 months before screening;\n15. Have a history of drug or drug abuse or urine drug abuse screening positive;\n16. Subjects who have special requirements for diet and cannot accept a unified diet;\n17. Have dysphagia;\n18. Female subjects are lactating or have positive serological pregnancy results.\n19. Acute illness or concomitant medication occurred between the screening stage and the administration of the investigational drug;\n20. Ingested chocolate, any food or drink containing caffeine or rich in xanthines within 24 hours before first taking the experimental drug;\n21. Subjects who taken any alcohol-containing product or a positive alcohol breath test in the 24 hours prior to the use of the study drug;\n22. The investigator believes that the subjects are not suitable to participate in the clinical study for other reasons.",true,"45 Years",{"count":78,"type":21},138,[24],"This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.",[82],"Nonalcoholic Steatohepatitis (NASH)",[84],"Adverse Event","2025-04-09",{"date":87,"type":33},"2025-04-11",{"date":89,"type":33},"2023-12-06",{"date":91,"type":21},"2025-08-01",{"name":38,"class":39},""]