[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Alphamab Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":136},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,90,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634877","phase-3-safety-of-kn057-prophylaxis-in-patients-with-haemophilia-a-or-b-100634877",false,"NCT07545395","Safety of KN057 Prophylaxis in Patients With Haemophilia A or B","An Open-label Study to Evaluate the Safety of KN057 Long-term Prophylaxis in Patients With Hemophilia A or Hemophilia B With or Without Inhibitors","Inclusion Criteria:\n\n1. Male, 12 to 65 years old at the time of signing informed consent, body weight ≥30 kg and BMI \\\u003C28 kg\u002Fm\\^2 at screening.\n2. For participates with inhibitors: Tested positive for high-titer FVIII or FIX inhibitors (≥ 5 BU\u002FmL) at screening; or tested positive for low-titer FVIII or FIX inhibitors (0.6 BU\u002FmL or upper limit of normal \\[ULN\\] \\\u003C inhibitor titer \\\u003C 5 BU\u002FmL) at screening, with ongoing treatment using bypassing agents (rFVIIa or PCC).\n\n   For participates without inhibitors: Severe and moderately severe hemophilia A or hemophilia B (FVIII or FIX activity level ≤2%); FVIII or FIX inhibitor test is negative (\\\u003C0.6 BU\u002Fml) or lower than the lower limit of laboratory normal values during the screening period; There is no history of FVIII or FIX inhibitors in the past, or there has been an inhibitor, but the inhibitor has turned negative for at least 5 years before screening and has not reappeared (no positive inhibitor was detected); Use coagulation factor replacement therapy for no less than 100 exposure days before screening.\n3. Participates with inhibitors agree to avoid using PCC for treatment when breakthrough bleeding occurred. Participates without inhibitors agree to be treated with standard half-life coagulation factors (FVIII or FIX) in the event of breakthrough bleeding.\n\nExclusion Criteria:\n\n1. Have serious or poorly controlled chronic diseases or obvious systemic diseases.\n2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic\u002Fantithrombotic therapy.\n3. Have high-risk factors for thrombosis: such as atrial fibrillation, atherosclerotic diseases of important arteries, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter.\n4. Known or suspected hypersensitivity to any constituent of the trial product or related products.\n5. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.\n6. Used Emicizumab treatment within 6 months before screening.\n7. Have received any gene therapy for hemophilia in the past.\n8. Other factors that the investigator deems inappropriate for participating in this trial, such as the presence of concomitant diseases, treatment or examination abnormalities that affect the subject's safety during the trial or affect the interpretation of trial results.","MALE","12 Years","65 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057.\n\nThe participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks.\n\nThe participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment.\n\nPriority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.",[27],"Hemophilia A or B","RECRUITING","2026-04-21",{"date":31,"type":32},"2026-04-22","ACTUAL",{"date":34,"type":32},"2026-03-13",{"date":36,"type":21},"2028-03-30",{"name":38,"class":39},"Suzhou Alphamab Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100608431","phase-1-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-kn060-in-esrd-dialysis-patients-100608431","NCT07201467","To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients","Phase 1b Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in Patients With End Stage Renal Disease Receiving Regular Hemodialysis","Inclusion Criteria:\n\n1. Male or female subjects aged between 18 and 80 years (inclusive);\n2. 1 8 kg \u002Fm \\^2 \\\u003CBMI \\\u003C2 8 kg \u002Fm\\^2 ;\n3. Diagnosis of ESRD and be receiving regular, stable hemodialysis treatment within the three months prior to screening: dialysis is performed through a functional, non-infected graft arteriovenous fistula \u002F autologous arteriovenous fistula ( AVG\u002FAVF ) ; dialysis is performed three times per week, with at least 3.5 hours per session ( at least 75% of dialysis sessions within the four weeks prior to randomization meet the this criteria) ;\n4. The clinical status of the underlying ESRD is stable (assessed by the investigator) ;\n5. Kt\u002FV ≥ 1.2 within 3 months before screening ;\n6. Male subjects: From the time they sign the informed consent form until 3 months after the last dose of KN060 , they agree to take effective contraceptive measures and avoid sperm donation ( effective contraceptive methods include: consistent scientific use of condoms , vasectomy , or partners who have undergone tubal ligation or hysterectomy, or have an intrauterine device implanted, etc. );\n7. Women who are infertile and have no plans to have children (surgical infertility: such as after hysterectomy, bilateral salpingectomy , bilateral oophorectomy; or natural menopause: amenorrhea for ≥ 12 months and serum follicle-stimulating hormone (FSH) at menopausal levels ).\n\nExclusion Criteria:\n\n1. A history of malignant tumor;\n2. History of mechanical\u002Fartificial heart valve replacement surgery;\n3. History of major medical events within 3 months before screening , such as acute coronary syndrome, stroke , major organ bleeding, acute heart failure, systemic thromboembolic events , major surgery, etc. , or history of AVF\u002FAVG functional loss;\n4. Using anticoagulant\u002Fantiplatelet drugs due to disease treatment , such as warfarin , dabigatran, rivaroxaban , clopidogrel , or aspirin \\>100 mg\u002Fday (investigators are allowed to use heparin \u002F low molecular weight heparin during dialysis, depending on the situation );\n5. There is a high risk of bleeding, or abnormal bleeding-related indicators:\n\n1） Bleeding requiring hospitalization or clinically significant active bleeding within 3 months before screening ; prolonged arteriovenous fistula compression time within the past month; 2） Platelet count (PLT) \\\u003C100 × 10\\^ 9 \u002FL ( PLT between 75-100 × 10\\^9 \u002FL , determined by the investigator after comprehensive evaluation), hemoglobin ( Hb ) \\\u003C 90 g\u002FL ; 3） Normalized ratio INR\\>1.4 , activated partial thromboplastin time ( APTT ) \\> 1.2 times ULN ; 4） Liver disease-related laboratory abnormalities: increased bleeding risk due to coagulation disorders , alanine aminotransferase (ALT) \\> 3 times ULN , aspartate aminotransferase ( AST) \\> 3 times ULN , total bilirubin (TB) \\> 2 times ULN and direct bilirubin proportion \\> 20%; 5） Poor blood pressure control in the past month before screening (judged by the investigator, such as repeated diastolic blood pressure ≥100 mmHg and\u002For systolic blood pressure ≥180 mmHg ) ; 6） Underwent brain, spinal or eye surgery (excluding cataract surgery) within three months before screening; 7） The patient has a bleeding disorder, a medical history that may increase the risk of bleeding, any condition that the investigator believes increases the risk of bleeding, or a history of severe bleeding disorders, such as massive gastrointestinal bleeding or cerebral hemorrhage ; 6. Supine blood pressure is \\\u003C 90\u002F50 mmHg , or \\> 170\u002F100 mmHg (one retest is allowed) during screening; 7. Electrocardiogram during screening: heart rate \\\u003C 45 beats \u002F min or \\> 110 beats \u002F min, QTcF \\> 500 ms, any significant arrhythmia or conduction abnormality ( e.g. Second degree or above atrioventricular block, preexcitation syndrome (except those who have undergone radical radiofrequency ablation) , non-sustained or sustained ventricular tachycardia (one retest is allowed); 8. History (\\\u003C1 year) of drug or alcohol abuse or dependence before screening; 9. Have a history of allergy, or be allergic to the experimental drug\u002Fsimilar drugs or excipients; 10. Human immunodeficiency virus (HIV ) infection, syphilis infection, active HBV infection (HBV -DNA\\>ULN ), active HCV infection (HCV - RNA \\> ULN ) ; 11. Participated in another clinical trial and received trial drugs within 3 months before screening (signing ICF); 12. Plan to receive a kidney transplant during the trial or within 3 months after completing this trial; 13. Xanthine, coffee (small amounts of caffeine from normal food sources, such as chocolate, are permitted), or alcohol cannot be prohibited during the study; 14. Any concomitant disease or condition that the investigator believes may interfere with the study drug, affect study data, or pose a risk to patient safety.","ALL","18 Years","80 Years",{"count":52,"type":21},12,[54,55],"PHASE1","PHASE2","The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis.\n\nThe secondary objectives to evaluate the pharmacokinetic and pharmacodynamic properties of multiple doses of KN060; to evaluate the immunogenicity of KN060; and to explore the efficacy of KN060 in preventing dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis in patients with end-stage renal disease undergoing regular hemodialysis. The main questions it aims to answer are:\n\n* Whether KN060 is safe for ESRD dialysis patients\n* Pharmacokinetic characteristics of KN060 in ESRD dialysis patients\n* Whether KN060 can effectively prevent dialyzer and extracorporeal circuit thrombosis Researchers will evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics profile, dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis of KN060 in ESRD dialysis patients\n\nSubjects will :\n\n* Eligible subjects will receive KN060 2.5 mg\u002Fkg every two weeks for a total of 6 doses.\n* Assessed for the number, incidence, and severity of AEs, dialyzer thrombus, extracorporeal circuit thrombus, arteriovenous fistula thrombus, and time to hemostasis at the arteriovenous fistula puncture site.",[58],"End-Stage Renal Disease Requiring Haemodialysis","2025-09-23",{"date":61,"type":32},"2025-10-01",{"date":63,"type":32},"2025-08-22",{"date":65,"type":21},"2027-12-15",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":40},"100607695","phase-1-to-evaluate-the-efficacy-and-safety-of-kn060-in-essential-hypertension-100607695","NCT07191899","To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension","Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension","Inclusion Criteria:\n\n1. men or women ≥ 18 years of age and ≤ 65 years of age;\n2. patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in antihypertensive drugs and doses within 30 days before screening);\n3. AOBP mean sitting SBP ≥ 140 and \\\u003C 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and mean SBP ≥ 130 and ≤ 160 mmHg at 24 hours ABPM;\n\nExclusion Criteria:\n\n1. secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP treatment;\n2. Grade 3 hypertension (severe): mean AOBP sitting SBP ≥ 180 mmHg, and\u002For DBP ≥ 110 mmHg; mean ABPM SBP \\> 160 mmHg, and\u002For mean DBP ≥ 100 mmHg;\n3. Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness, irritability, and epistaxis;\n4. high risk of bleeding or abnormal relevant indicators;\n5. long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;\n6. currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;\n7. Type 2 diabetes with substandard blood glucose control: fasting blood glucose \\> 7.8 mmol\u002FL, or 2-hour postprandial blood glucose\u002Frandom blood glucose \\> 10.0 mmol\u002FL, or HbA1c \\> 7%;\n8. any cardiovascular event within 6 months prior to screening\n9. unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, heart failure NYHA ≥ III, severe left ventricular hypertrophy, or a history of valvular heart disease;\n10. 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;\n11. echocardiography revealed heart failure:LVEF\\\u003C 50%; abnormal ventricular diastolic function",{"count":75,"type":21},60,[54],"The primary objective of this study is to compare the change from baseline in systolic blood pressure between KN060 and placebo in patients with essential hypertension over 12 weeks; the secondary objectives are to assess the safety and tolerability of KN060 and to assess the pharmacokinetic and pharmacodynamic properties and immunogenicity of KN060 in patients with essential hypertension.\n\nThe main questions it aims to answer are:\n\n* To verify the efficacy of KN060 in patients with essential hypertension\n* Safety of KN060 in Subjects Treated for Essential Hypertension Researchers will compare KN060 to placebo (0.9% sodium chloride 100ml) to assess the antihypertensive effect of KN060.\n\nSubjects will :\n\n* Receive KN060 or placebo by intravenous drip every two weeks for 6 doses.\n* AOBP, 24hABPM, HBPM,and safety were monitored and recorded.",[79],"Hypertension",[81],"Essential hypertension","2025-09-22",{"date":84,"type":32},"2025-09-25",{"date":86,"type":32},"2025-08-05",{"date":88,"type":21},"2027-12-30",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":16,"minAge":49,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":40},"100558181","phase-1-a-study-to-evaluate-features-of-kn069-in-participants-with-obesity-or-overweight-100558181","NCT06547775","A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight","A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN069 in Chinese Male Participants With Obesity or Overweight","Inclusion Criteria:\n\n1. Male, 18-55 years old (including threshold);\n2. Body mass index (BMI)：24.0 kg\u002Fm2≤BMI\\\u003C35 kg\u002Fm2；\n3. HbA1c\\\u003C6.5%；3.9mmol\u002FL≤Fasting blood glucose level \\\u003C7.0mmol\u002FL；\n4. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions; Are able and willing to sign the ICF.\n\nExclusion Criteria:\n\n1. Those who have a history of chronic diseases or are currently suffering from obvious systemic diseases, such as diseases of cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, autoimmune system, neurological or psychiatric system, bacterial or viral infection;\n2. History of acute or chronic pancreatitis; A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2; A history of other malignancies;\n3. History of GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors;\n4. Participants had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past;\n5. Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category;\n6. A history of medicine abuse\u002Fdependence or narcotics abuse within 1 year prior to the screening and\u002For show positive findings on urinary drug screening;\n7. Have undergone any major surgery or surgery affecting drug absorption, distribution, metabolism, excretion within the 3 months prior to screening, or are scheduled to undergo surgery during the trial period (major surgery is defined as surgery on the intracranial, chest, abdomen, pelvic, or limb organs that result in major tissue trauma and require long-term recovery).\n8. Drinking more than 14 units of alcohol per week (1 unit =360ml beer or 45ml liquor with 40% alcohol or 150ml wine) in the 3 months before or during the screening period, alcohol cannot be banned during the hospital stay, and alcohol consumption cannot be limited to less than 2 units of alcohol per day during the post-discharge visit.\n9. Blood donation or blood loss ≥ 300 mL within 3 months prior to screening, or blood\u002Fblood components donation planned during the trial or within 1 month after the final study visit.\n10. Received administration of other drugs\u002Fvaccines in clinical trials within 2 months prior to screening; In other clinical trials at the time of screening;\n11. People who diet or undergo weight loss treatment within 2 months (for whatever reason) before administration, or who have made significant changes in their lifestyle habits.;\n12. Received vaccination within 14 days prior to screening, or have vaccination schedule during the trial, including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, COVID-19 vaccine;\n13. Use medication (including prescription drugs, over-the-counter drugs, herbal medicine) with the exception of vitamin\u002Fmineral supplements, paracetamol, topical medication, and contraceptives within 14 days prior to dosing.\n14. Use of GLP-1 analogues, GLP-1 receptor agonists, or any other formulations related to incretin and other drugs that the investigator believes may affect the trial within the 3 months prior to administration.\n15. Any abnormal patients who met the following criteria during screening: 1) serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) exceeded the upper limit of the reference value range by 2 times; Serum total bilirubin (TBIl) exceeded 1.5 times the upper limit of the reference value range; 2) Fasting triglyceride (TG) ≥5.6mmol\u002FL; 3) Physical examination, vital signs, electrocardiogram, laboratory examination, imaging and other abnormalities have clinical significance, and the investigator judges that they may pose a major risk to the subjects or interfere with the evaluation of safety, PK or PD results and are not suitable to participate in the trial;\n16. Positive breath test for alcohol (\\>0 mg\u002F100 mL);\n17. Evidence of hepatitis B\u002Fhepatitis C\u002FHIV\u002Fsyphilis.\n18. Urine screen positive for drug abuse.\n19. Participants that refuse to stay abstinent, and refuse to consistently use a form of highly effective birth control method starting at Screening (signing the ICF) and continuing throughout the clinical study period, and to 3 months after administration of IP; or to have a birth plan during the screening period until 3 months after dosing;\n20. Participants that plan to donate sperms from dosing until 3 months after administration of IP.\n21. Due to trauma, surgery, allergies or skin lesions, the abdominal skin is not suitable for subcutaneous injection.\n22. Other factors that the investigator considers unacceptable for participation in the study.",true,"55 Years",{"count":100,"type":21},36,[54],"This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN069 in Chinese male participants with Obesity or Overweight.",[104],"Overweight or Obesity","2025-09-16",{"date":107,"type":32},"2025-09-17",{"date":109,"type":32},"2024-08-02",{"date":111,"type":21},"2027-06-30",{"name":38,"class":39},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100573525","phase-2-kn057-multiple-dose-study-in-patients-with-hemophilia-a-or-hemophilia-b-with-or-without-inhibitors-100573525","NCT06747416","KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors","A Phase II Multicenter, Open Label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and PK\u002FPD Profile of Multiple Subcutaneous Injection of KN057 in Male Patients with Severe Hemophilia a or Moderate-to-Severe Hemophilia B with or Without Inhibitors","Inclusion Criteria:\n\n1. Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI \\\u003C30 kg\u002Fm\\^2.\n2. Severe Hemophilia A or moderate-to-severe Hemophilia B (coagulation factor FVIII activity \\\u003C1% or FIX activity ≤2%).\n3. Have ≥ 6 treated bleeding episodes within 24 weeks prior to screening (spontaneous and\u002For traumatic, excluding bleeding episodes related to surgery or traumatic operation).\n4. Patients without inhibitors must meet the following criteria: FVIII or FIX inhibitor test is negative during the screening period. Use coagulation factor replacement therapy for no less than 100 exposure days before screening.\n5. Patients with inhibitors must meet the following criteria: FVIII or FIX inhibitor test is positive during the screening period. Inhibitors level with high titer positive (≥5 BU\u002Fml) or current low titer positive (\\\u003C5 BU\u002Fml) refractory to FVIII or FIX replacement and with FVIII or FIX recovery \\\u003C 60% of expected within previous 12 months prior to screening.\n\nExclusion Criteria:\n\n1. Those with serious or poorly controlled chronic diseases or obvious systemic diseases: such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, neurological diseases or psychiatric diseases, bacterial or viral infection, etc.; have previously received lipid-lowering therapy for hypertriglyceridemia or are currently receiving lipid-lowering therapy for hypertriglyceridemia.\n2. Have a history of other hereditary or acquired bleeding disorders other than Hemophilia A and Hemophilia B.\n3. Have symptoms and signs related to thromboembolic disease or are receiving thrombolytic\u002Fantithrombotic treatment; have a history of coronary atherosclerotic disease, arterial or venous thrombosis, or ischemic disease of important organs.\n4. Have high risk factors for thrombosis, including reduced activity of antithrombin III, protein S or protein C.\n5. When bleeding occurred in the past, rFVIIa was ineffective and (activated) prothrombin complex concentrate (PCC\u002FaPCC) treatment must be used.\n6. Are undergoing or planning to undergo immune tolerance induction therapy.\n7. Regular use of immunomodulatory therapy, such as regular infusion of immune globulin or regular use of hormones, is required.\n8. Those with allergies; those who are allergic to test drugs\u002Fsimilar drugs or excipients; those with a history of multiple allergies (two categories or more); those with a history of specific reactions, such as being allergic to heparin or having experienced heparin-induced thrombocytopenia.\n9. Hematological abnormalities: platelet count ≤ 100 × 10\\^9 \u002FL; hemoglobin \\\u003C 100g\u002FL; fibrinogen level \\\u003C lower limit of normal (LLN); prothrombin time \\> 1.5 times upper limit of normal (ULN).\n10. Abnormal liver and kidney function: alanine aminotransferase and\u002For aspartate aminotransferase \\>3 times ULN; lactate dehydrogenase \\>1.5 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine, triglyceride \\> ULN; albumin \\\u003C0.8 times LLN.\n11. Chronic active hepatitis B\u002FC virus (HBV\u002FHCV, HBV-DNA or HCV-RNA quantitative detection indicates viral activity); Human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; Have received antiviral treatment (only for HBV, HCV, and HIV) in the past 3 month, or have plans to undergo antiviral treatment within 28 weeks after the first dose.\n12. Have had major surgery within the past 3 months (determined by the investigator), or have elective surgery planned within 28 weeks after the first dose.\n13. Due to treatment needs, anti-fibrinolytic or platelet function-affecting drugs need to be used within 5 days before administration or within 28 weeks after the first administration, including medicines, such as aspirin, COX-1 and non-selective non-steroidal anti-inflammatory drugs (NSAIDs, except for acetaminophen), traditional herbal medicine or health supplements at investigator's discretion.\n14. Participated in clinical trials related to coagulation factors and received investigational drug treatment within the past 1 month; participated in any other drug clinical trials and received investigational drug treatment within the past 3 months.\n15. Have been vaccinated in the past month, or have a vaccination plan within 28 weeks after the first dose, including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, etc.\n16. Subjects with fertile mates are unable to use effective contraception during the study period and within 3 months after the last dose; effective contraceptive methods include: vasectomy, scientific use of male condoms, etc.\n17. Have had treatment of Emicizumab within 6 months prior to screening;\n18. Have had any prior treatment of genetic therapy for hemophilia.\n19. Those participants who drink heavily or are alcoholic within 24 weeks prior to screening or can't avoid heavy drinking during the trial. Heavy drinking means more than 7 units of alcohol per week, 1 unit=360ml of beer, or 45ml of liquor with 40% alc\u002Fvol, or 150ml of wine.\n20. Other factors that the investigator considers inappropriate for participation in this trial.","70 Years",{"count":122,"type":21},24,[55],"The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \\\u003C1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.",[126],"Hemophilia a and B","NOT_YET_RECRUITING","2024-12-18",{"date":130,"type":32},"2024-12-24",{"date":132,"type":21},"2025-09-02",{"date":134,"type":21},"2026-12-31",{"name":38,"class":39},""]