[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kexing Biopharm Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"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},"100544014","phase-3-human-interferon-1b-inhalation-solution-against-respiratory-syncytial-virus-in-children-with-lower-respiratory-tract-infections-100544014",false,"NCT06363370","Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.","Inclusion Criteria:\n\n1. 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-\\[(37 weeks-fetal age)\u002F4\\], gender is not limited;\n2. Comply with the following diagnostic criteria:\n\n1\\) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and\u002For asthma, lung auspicious pitch and\u002For wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and\u002For thick lung texture\u002Fslightly\u002Fmore and\u002For emphysema and\u002For the signs of inflammation around the bronchial.\n\n3\\. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent.\n\nExclusion Criteria:\n\n1. There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the \"eczema area and severity index\" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen);\n2. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and\u002For maxillofacial deformities, which affects the use of atomization inhalation;\n3. Those who have genetic metabolic diseases;\n4. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；\n5. Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body;\n6. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.\n7. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;\n8. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;\n9. Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy;\n10. During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease;\n11. During the screening, the thoracic effusion, pydion and pus, and pus, etc.;\n12. Merce able goose sores suspected mold infection during screening；\n13. The laboratory inspection is abnormal during screening:1) White blood cell count\\>14x109\u002FL (or normal value of normal value) or neutral granulocyte ratio\\> 70%, and researchers comprehensively judge suspects as merging bacterial infections;2) Excisibility of liver function test: Alanine aminotransferase (ALT) or permine aminamidase (AST)\\> The upper limit of the normal value is 2 times, or the total biliary erythrin\\> 1.5 times the upper limit of the normal value;3) Blood routine abnormalities: white blood cell count \\\u003C3.5X109\u002FL and\u002For platelet count≤100x109\u002FL；\n14. Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing;\n15. After the history of the history of the disease, the child known (or the mother who is younger than 6 months old) is HIV -positive, or the researcher is highly suspected of being HIV -positive;\n16. In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs;\n17. Volunteers may not be able to complete this study or researchers who believe that they are not suitable for participating in this clinical trial due to various reasons.","ALL","2 Months","2 Years",{"count":20,"type":21},322,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.",[27],"Respiratory Syncytial Virus Infections","RECRUITING","2026-06-28",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2024-03-27",{"date":36,"type":21},"2027-06-30",{"name":38,"class":39},"Kexing Biopharm 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":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100632890","phase-1-a-phase-i-clinical-study-to-evaluate-the-efficacy-and-safety-of-gb18-injection-in-patients-with-tumor-cachexia-100632890","NCT07519564","A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia","A Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia","Key Inclusion Criteria:\n\n* Voluntarily serve as a participant and sign the informed consent form;\n* Age ≥ 18 years;\n* Histologically or cytologically confirmed, non-resectable, locally advanced, recurrent, or metastatic solid tumors with failed standard treatment or have no standard treatment options. This includes, but is not limited to, colorectal cancer, pancreatic cancer, gastric cancer, esophageal cancer, biliary tract cancer, non-small cell lung cancer, prostate cancer, breast cancer, or ovarian cancer.\n* Diagnosed with cancer cachexia: BMI \\\u003C 18.5 kg\u002Fm², and no unintentional weight loss \\> 2% within 6 months before screening, or no unintentional weight loss \\> 5% within 6 months before screening regardless of BMI.\n* A serum GDF15 concentration ≥ 1.5 ng\u002FmL.\n* Laboratory Test Requirements:\n\n  1. Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL, platelet count ≥ 75 × 10⁹\u002FL, hemoglobin ≥ 80 g\u002FL.\n  2. Serum creatinine ≤ 1.5 × ULN (Upper Limit of Normal).\n  3. Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN for patients with liver metastasis).\n  4. Activated partial thromboplastin time ≤ 1.5 × ULN, International Normalized Ratio ≤ 1.5.\n  5. Left Ventricular Ejection Fraction \\> 50% as assessed by echocardiogram.\n* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2 points\n* Expected survival period ≥ 4 months.\n\nKey Exclusion Criteria:\n\n* Known active\u002Fsymptomatic central nervous system metastases and\u002For carcinomatous meningitis.\n* Plan to receive radiotherapy as a component of the primary antitumor treatment regimen.\n* BMI \\> 26 kg\u002Fm².\n* Presence of reversible causes for reduced food intake, including but not limited to NCI CTCAE grade 3 or 4 oral mucositis; NCI CTCAE grade 3 or 4 nausea, vomiting, diarrhea, or constipation; mechanical obstruction preventing oral intake.\n* Comorbid conditions unrelated to tumor cachexia that cause difficulty in eating or malabsorption.\n* Cachexia due to other investigator-determined or clearly defined causes. History within the past 6 months of any of the following: myocardial infarction, congenital long QT syndrome, second- or third-degree atrioventricular block, arrhythmias (including sustained ventricular tachycardia or ventricular fibrillation), unstable angina, acute coronary syndrome, symptomatic congestive heart failure (NYHA class III or IV) of coronary or peripheral origin, stroke, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant thromboembolic disease.\n* Hypertension with unsatisfactory control despite antihypertensive therapy (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 90 mmHg).\n* Patients receiving tube feeding or parenteral nutrition (total or partial) within 28 days before the first administration of the investigational drug.\n* Initiation of new systemic glucocorticoid therapy from 28 days before the first dose of the investigational drug to the end of the study.\n* Major surgery not yet recovered from within 28 days before the first dose of the investigational drug (central venous access placement and tumor biopsy are not considered major surgery), or anticipated major surgery during the study period.\n* Prior participation in clinical trials targeting the GDF-15\u002FGFRAL signaling pathways, or receipt of other investigational agents within 28 days or five half-lives (whichever is shorter) before the first dose of the investigational drug.\n* Severe infection requiring intravenous antibiotics, antivirals, or antifungal agents within 14 days before the first dose of the investigational drug.","18 Years",{"count":50,"type":21},18,[52],"PHASE1","KXZY-GB18-101(1B) is an extension of KXZY-GB18-101, a first-in-human, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.\n\nAs a humanized GDF15 monoclonal antibody, GB18 is expected to improve anorexia and weight loss caused by metabolic disorders driven by overactivation of the GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, this study aims to evaluate the effects of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (B1-B3, each with 6-12 participants).",[55],"Cachexia; Cancer",[57,58,59,60],"Cachexia","Cancer","GB18","First-in-patient","2026-06-10",{"date":63,"type":32},"2026-06-12",{"date":61,"type":32},{"date":66,"type":21},"2027-12-30",{"name":38,"class":39},2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100635489","phase-3-gb06-phase-iii-trial-for-pediatric-growth-hormone-deficiency-100635489","NCT07553351","GB06 Phase III Trial for Pediatric Growth Hormone Deficiency","A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Trial to Study the Efficacy and Safety of Human Growth Hormone Injection (GB06) in Treating Growth Disorders Caused by Pediatric Growth Hormone Deficiency","Inclusion Criteria:\n\n1. The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.\n2. Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);\n3. Height below two standard deviations (SD) of the average height of children of the same age and gender;\n4. Annual height velocity (AHV) \\\u003C5cm\u002Fyear, based on height within 6 months to 18 months before screening;\n5. Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;\n6. Short stature with normal intellectual development;\n7. Tanner stage I (testicular volume \\\u003C4ml for boys, no palpable breast gland tissue for girls);\n8. IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;\n9. Bone age lags behind the chronological age;\n10. Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng\u002Fml;\n11. A standard karyotype of 46, XX for girls.\n\nExclusion Criteria:\n\n1. Known allergy to ingredients of the study drug;\n2. Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;\n3. Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;\n4. Small for gestational age;\n5. Epiphyseal closure;\n6. Congenital intracranial hypertension;\n7. Slipped capital femoral epiphysis;\n8. GHD secondary to another pituitary hormone deficiency;\n9. Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;\n10. History of fundus lesions (optic nerve papilledema lesions);\n11. Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol\u002FL or hemoglobin A1c (HbA1c) ≥ 6.5%;\n12. Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;\n13. Expected requirement to inhale budesonide \\>400μg\u002Fday or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;\n14. Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene abnormality, GH receptor deletion, or other significant genetic mutations causing short stature; Significant spinal abnormalities, including but not limited to scoliosis, kyphosis, and spina bifida; Congenital anomalies (resulting in skeletal abnormalities), including but not limited to Russell-Silver syndrome and bone dysplasia; Family history of bone dysplasia;\n15. Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction \\[e.g., alanine aminotransferase (ALT)\\> 1.5 times the upper limit of normal, creatinine (Cr) \\>upper limit of normal value\\], malnutrition, severe cardiopulmonary and hematological diseases, systemic infection, immunodeficiency, mental abnormalities, and other congenital malformations;\n16. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, and tuberculosis. Hepatitis B virus DNA levels will be assessed in individuals who are positive for HBV surface antigen.\n\n    A hepatitis C virus RNA test is required if the hepatitis C virus antibody test is positive. Quantitative results below the lower limit of detection will be excluded.\n17. Concomitant use of other treatments that may affect growth, including but not limited to methylphenidate for attention deficit hyperactivity disorder;\n18. History of drug or alcohol abuse;\n19. Children with hypothyroidism and\u002For adrenal insufficiency who have not received adequate stable replacement therapy lasting at least 90 days before randomization;\n20. Other diseases that the investigator believes may endanger the safety of the participant or protocol compliance;\n21. Potentially poor compliance in this study.\n22. Other conditions that the investigator deems unsuitable for inclusion.","3 Years","11 Years",{"count":79,"type":21},192,[24],"This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.\n\nIt aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg\u002Fkg\u002Fday for 52 consecutive weeks.",[83,84,85],"Growth Hormone Deficiency (GHD)","Growth Hormone Deficiency in Children","Growth Hormone Deficiency, Pediatric",[87,88,89,90,91,92],"Growth Hormone","Growth Hormone Deficiency","Annual Height Velocity","Insulin-like Growth Factor-1","Bone Age","GB06","2026-06-07",{"date":61,"type":32},{"date":96,"type":32},"2026-06-06",{"date":98,"type":21},"2028-10-24",{"name":38,"class":39},""]