[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Kanova Biopharmaceutical Co., LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100651191","phase-1-bridging-study-of-xkh001-in-healthy-adult-caucasian-participants-100651191",false,"NCT07757659","Bridging Study of XKH001 in Healthy Adult Caucasian Participants","A Phase Id, Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Bridging Study To Evaluate The Pharmacokinetics, Safety, Tolerability, and Immunogenicity of XKH001 in Healthy Adult Caucasian Participants","Inclusion Criteria:\n\n1. Healthy participants who voluntarily provide written informed consent and can comply with all study procedures according to the protocol.\n2. Male or female participants of Caucasian ethnicity(both biological parents and all four grandparents of Caucasian origin), 18-65 years of age (inclusive).\n3. Body mass index (BMI) between 18.0-32.0 kg\u002Fm² (inclusive).\n4. Vital signs, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) within normal limits or considered not clinically significant by the investigator, with QTcF ≤450 ms.\n5. No use of prescription or over-the-counter medications within 4 weeks prior to first dosing.\n6. Participants must meet the sex- and reproductive-status-specific contraception and gamete-donation requirements specified in Appendix 2. Where contraception is required, the participant must agree to use the protocol-specified established effective contraception from the time of signing the informed consent form until 7 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Any clinically significant disease within 5 years that could affect participation (gastrointestinal, renal, hepatic, pulmonary, neurology, Haematology, endocrine, oncology, metabolic, psychiatric, or cerebrovascular).\n3. History of autoimmune disease, known hereditary immunodeficiency, or recurrent infections suggesting immunodeficiency.\n4. Active infection requiring hospitalisation or IV antibiotics within 3 months, or clinically symptomatic bacterial, viral, or fungal infection within 4 weeks prior to first dosing.\n5. Active or latent tuberculosis infection.\n6. HBsAg positive, HCV antibody positive, syphilis antibody positive, or HIV antigen\u002Fantibody positive.\n7. Live or attenuated vaccine within 4 weeks prior to dosing or planned during trial.\n8. Participation in any clinical trial within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to dosing.\n9. History of allergy to the investigational drug, any formulation component, or protein-based drugs.\n10. Alcohol consumption \\>14 units\u002Fweek within 6 weeks prior to screening, or alcohol-containing products within 1 day before dosing (1 unit = 8 g or 10 mL of pure alcohol).\n11. Drug abuse or illicit substance use within 5 years, or positive urine drug screen(A positive cotinine result alone is not exclusionary).\n12. Smoking history (\\>5 cigarettes\u002Fday) within 3 months prior to screening.\n13. Blood donation or loss \\>450 mL within 8 weeks, or \\>200 mL blood donation or \\>300 mL blood loss within 1 month.\n14. Unsuitable venous access or intolerance of venipuncture.\n15. Prior exposure to any anti-IL-25 therapeutic agent, including XKH001 or any other investigational or approved therapeutic agent targeting IL-25.\n16. Any other reason deemed unsuitable by the investigator.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},2,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase Id, randomised, double-blind, placebo-controlled, multiple-dose, bridging study conducted at a single Phase I clinical research unit in Australia. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of XKH001 following repeated subcutaneous administration in healthy adult Caucasian participants, and to provide an ethnic-bridging pharmacokinetic comparison with the prior Phase I dataset in Chinese participants, required for XKH001's global development programme.",[28],"Healthy Adult","NOT_YET_RECRUITING","2026-08-05",{"date":32,"type":33},"2026-08-11","ACTUAL",{"date":35,"type":22},"2026-08-01",{"date":37,"type":22},"2027-08-01",{"name":39,"class":40},"Zhejiang Kanova Biopharmaceutical Co., LTD","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100632885","phase-2-phase-ii-clinical-study-to-evaluate-the-efficacy-and-safety-of-xkh001-injection-100632885","NCT07519499","Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection","Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection in Trial Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Trial participants must meet all of the following inclusion criteria to be enrolled in this study:\n\n  1. The trial participant is able to understand the procedures and methods of this study, is willing to sign the ICF and strictly adhere to the clinical study protocol to complete this study, and can independently complete study-related questionnaires;\n  2. The trial participant must be aged 40-80 years (inclusive) at the time of signing the ICF, can be either male or female;\n  3. The trial participant has a BMI ≥16.0 kg\u002Fm2;\n  4. Trial participants diagnosed with COPD for ≥12 months (diagnosed according to GOLD 2024) and meeting the following criteria:\n\n     * Current smoker or ex-smoker with a smoking history of ≥10 pack-years (1 pack-year is calculated as: \\[average number of cigarettes smoked per day × number of years\\]\u002F20; e.g., 1 pack-year = smoking 20 cigarettes per day for 1 year, or smoking 10 cigarettes per day for 2 years.); Moderate to severe airflow limitation (post-bronchodilator FEV1\u002FFVC \\\u003C70%, post-bronchodilator FEV1 measurement ≥30% and \\\u003C80% of predicted value);\n     * Documented high risk of exacerbations, defined as ≥2 moderate or ≥1 severe exacerbations in the year prior to screening: A moderate exacerbation is defined as an AECOPD requiring the use of systemic corticosteroids (intramuscular, intravenous, or oral) and\u002For antibiotics (however, the use of antibiotics alone does not qualify as a moderate exacerbation unless it is documented that the antibiotic use was necessary to treat worsening COPD symptoms); one of the two required moderate exacerbations must have required systemic corticosteroids; a severe exacerbation is defined as an AECOPD requiring hospitalization or observation in an emergency room\u002Furgent care facility for \\>24 hours;\n     * Received inhaled background maintenance therapy \\[triple therapy (ICS + LABA + LAMA) or dual therapy (LABA + LAMA or ICS + LABA)\\] for ≥3 months before randomization, with a stable dose for at least 1 month before signing the ICF and during the screening period;\n  5. Whole blood EOS count ≥150\u002FμL during the screening period;\n  6. Female trial participants of childbearing potential and their male partners, and male trial participants and their female partners, must agree to use an effective method of contraception during the study and for 6 months after the last dose of investigational drug, and have no plans for childbirth, sperm donation, or ovum donation (see Appendix 1: Contraceptive Measures, Definition of Childbearing Potential, and Contraception Requirements for details).\n\nExclusion Criteria:\n\n* Trial participants with any of the following cannot be enrolled in this study:\n\n  1. Presence of any respiratory disorder other than COPD, including:\n\n     * Current diagnosis of asthma or a history of asthma according to the GINA or other recognized guidelines;\n     * Diagnosis of alpha-1 antitrypsin deficiency;\n     * Other concomitant active or clinically significant respiratory disorders that would significantly affect the study: such as active pulmonary tuberculosis, lung cancer (including suspected malignant pulmonary nodule \\[Category 4\\]), bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung disease, cystic fibrosis, obliterative bronchiolitis, pulmonary arterial hypertension, etc.;\n  2. AECOPD (including mild, moderate, and severe; for definitions of moderate and severe AECOPD, see Inclusion Criterion 4, item 3) and\u002For respiratory tract infection within 4 weeks prior to screening and before randomization;\n  3. Signs and\u002For symptoms of cor pulmonale and\u002For right ventricular failure;\n  4. Hypercapnia requiring the use of BiPAP;\n  5. Currently receiving or planning to start long-term oxygen therapy (\\>15 hours of oxygen per day) or mechanical ventilation during the study;\n  6. Participation or planned participation in an intensive COPD rehabilitation program within 4 weeks prior to screening (trial participants in the maintenance phase of a rehabilitation program may be considered for enrollment);\n  7. Planned pulmonary resection or lung volume reduction surgery, or a history of such surgery;\n  8. Presence of any Grade ≥2 (NCI-CTCAE version 6.0) lipid profile abnormalities (the influence of physiological factors such as diet should be excluded);\n  9. Concomitant autoimmune disease requiring systemic immunosuppressant therapy (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis);\n  10. Known or suspected history of an immunosuppressive disease, including a history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved\u002Fsubsided; or, in the investigator's judgment, a history of abnormally frequent, recurrent, or prolonged infections;\n  11. Confirmed active infection parasitic; suspected infection parasitic or high risk of infection, unless clinical assessment and (if necessary) laboratory assessment have ruled out active infection before randomization;\n  12. Confirmed acute or chronic infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitic, or antiprotozoals within 4 weeks prior to screening or during the screening period;\n  13. Undergone Grade III or IV surgery (as defined in the \"Administrative Measures for the Grading of Medical Institution Surgeries\", see Appendix 2: Surgical Grading Management for details) within 12 weeks prior to screening (excluding paracentesis biopsy); or planned surgery requiring general anesthesia or hospitalization \\>1 day during the study;\n  14. Presence of other serious diseases that, in the investigator's judgment, may affect the patient's participation in this trial, including but not limited to: diseases that severely affect survival, uncontrolled diabetes mellitus, renal insufficiency requiring dialysis, Child-Pugh Class B\u002FC liver function, demyelination diseases, neurological and psychological disorders, etc.;\n  15. Clinically significant cardiovascular disorder within 6 months prior to screening. Cardiovascular disorders include but are not limited to:\n\n      * Two-dimensional echocardiogram showing an LVEF \\\u003C50%;\n      * Acute myocardial infarction;\n      * Severe\u002Funstable angina;\n      * History of arterial thromboembolism, including but not limited to cerebrovascular accident and transient ischemic attack;\n      * Cardiac failure congestive (NYHA functional class \\>II);\n      * Any clinically significant abnormality in rhythm, conduction, or morphology on a resting ECG, complete bundle branch block left, third-degree heart block, second-degree heart block, PR interval \\>250 msec;\n      * Mean resting QTc interval ≥500 msec obtained from 3 ECGs (corrected using Fridericia's formula, see Appendix 3: Calculation Formulas for QTcF and RR for details);\n      * Any factor that increases the risk of QTc interval prolongation or arrhythmic events, such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval;\n      * Hypertension not controlled by antihypertensive medication (blood pressure systolic \\>160 mmHg and\u002For blood pressure diastolic \\>100 mmHg);\n  16. Trial participants with a neoplasm malignant within 5 years prior to screening or currently (Note: ① Trial participants with carcinoma in situ of the cervix that has been resected, adequately treated, and currently has no evidence of disease recurrence may participate in this study; ② Trial participants with basal cell carcinoma or squamous cell carcinoma of the skin that has been completely resected, adequately treated, and currently has no evidence of disease recurrence may participate in this study);\n  17. Patients receiving the following drugs or treatments that are prohibited as concomitant therapy:\n\n      * Prior use of biologics with efficacy in treating COPD, such as Benralizumab, Mepolizumab, Omalizumab, Dupilumab, etc. (for Phase IIb, enrollment may be considered based on use and therapeutic effect, as assessed by the investigator);\n      * Received aminophylline, PDE-4 inhibitors, leukotriene receptor antagonists, and other systemic treatments for COPD within 2 weeks or 5 t1\u002F2 (whichever is longer) before the first dose;\n      * Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal use of corticosteroids) or systemic immunosuppressants\u002Fimmunomodulators (e.g., Methotrexate) within 4 weeks before the first dose;\n      * Use of Chinese herbal medicines with therapeutic effects on COPD (excluding topical preparations) within 4 weeks before the first dose;\n      * Received IVIG therapy or allergen-SIT within 8 weeks or 5 t1\u002F2 (whichever is longer) before the first dose;\n      * Received B- and\u002For T-cell targeted immunosuppressive therapy within 8 weeks or 5 t1\u002F2 (whichever is longer) before the first dose;\n      * Planned vaccination with a live or live-attenuated vaccine within 12 weeks before the first dose or during the study;\n      * Received other biologics such as anti-TNF monoclonal antibody therapy within 16 weeks or 5 t1\u002F2 (whichever is longer) before the first dose;\n      * Received macrolide antibiotic therapy within 6 weeks prior to screening (except for those who had been on a stable dose of macrolide antibiotics for ≥6 months prior to screening and had at least 1 AECOPD during this period).\n  18. Received blood products such as human blood albumin, hematopoietic growth factors (e.g., G-CSF), or platelet-increasing therapy within 2 weeks prior to screening;\n  19. Any of the following abnormalities in laboratory test results at screening:\n\n      * ANC \\\u003C1.5 × 109\u002FL;\n      * TBIL \\>1.5 × ULN;\n      * AST or ALT \\>2 × ULN;\n      * Creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula);\n      * PLT \\\u003C90 × 109\u002FL;\n      * HGB \\\u003C90 g\u002FL;\n      * Other clinically significant laboratory test abnormalities that, in the investigator's judgment, make the participant unsuitable for enrollment; Note: If a laboratory test result exceeds the protocol-specified threshold but is suspected to be transient (due to physiological factors, test error, etc.), or is only slightly above the threshold, it may be re-tested once (and only once) during the screening period for clarification. If the re-test result still exceeds the threshold, the trial participant will be a screen failure;\n  20. Presence of any of the following infectious diseases:\n\n      * Positive for HBsAg, or negative for HBsAg but positive for HBcAb and positive for HBV-DNA; positive for HCV-Ab and positive for HCV-RNA;\n      * Positive for TP-Ab (unless negative on RPR or TRUST);\n      * Positive for HIV antibody;\n  21. History of severe allergic reaction or known allergy to XKH001 Injection or its excipients;\n  22. History of fainting at the sight of blood or from needles;\n  23. Pregnant or lactating females;\n  24. Blood donation or blood loss of ≥400 mL within 12 weeks prior to screening, or received a transfusion within 4 weeks prior to screening;\n  25. Participation in any other clinical study (including drug and device studies) and use of an investigational drug or medical device intervention within 12 weeks or 5 t1\u002F2 (whichever is longer) prior to screening (calculated from the time of the last use of the investigational drug or medical device intervention);\n  26. History of alcohol abuse or various drug abuse within 2 years prior to signing the ICF;\n  27. Other factors that, in the investigator's opinion, make the participant unsuitable for the study.","40 Years","80 Years",{"count":52,"type":22},75,[54],"PHASE2","This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.",[57],"COPD","2026-04-06",{"date":60,"type":33},"2026-04-09",{"date":62,"type":22},"2026-04-01",{"date":64,"type":22},"2028-02-01",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100597149","phase-2-evaluate-the-efficacy-and-safety-of-xkh001-injection-in-patients-with-moderate-to-severe-atopic-dermatitis-100597149","NCT07054736","Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Subjects must meet all the following criteria to be eligible for participation in this study:\n\n  1. Both males and females, aged 18 to 65 years (inclusive) on the day of signing the informed consent;\n  2. Diagnosed with Atopic dermatitis according to the American Academy of Dermatology consensus criteria (2014) and with a history of disease for at least 6 months prior to signing the informed consent;\n  3. At the screening and baseline visits, the severity of Atopic dermatitis is classified as moderate to severe, that is, the following 4 conditions are met simultaneously; Eczema Area and Severity Index (EASI) score ≥ 16 points; Investigator's Global Assessment (IGA) score ≥ 3 points; Percent Body Surface Area (BSA) ≥10%; Weekly mean of daily Peak Pruritus Numerical Rating Scale (NRS) score ≥ 4 points;\n  4. If the investigator determines that topical drug therapy used within 6 months prior to signing the informed consent was insufficiently effective or unsuitable, at least one of the following conditions must be met:\n\n     Received ≥ 4 weeks of medium\u002Fpotent topical corticosteroids (TCSs) or ≥ 2 weeks of super potent TCSs (combined with the longest treatment course recommended in the drug instructions, whichever is shorter) ± topical calcineurin inhibitors (TCIs), but did not achieve and maintain remission or a lower disease activity state (equivalent to IGA = 0 to 2); Received systemic corticosteroids (SCSs) and other systemic treatments for AD is also considered an insufficient response to topical drug therapy; Not suitable for topical drug therapy (e.g., intolerance or contraindications);\n  5. Application of a stable dose of basic, mild, inactive ingredient-free topical emollients (moisturizers) twice daily for at least 7 consecutive days before the first dose and throughout the study.\n  6. Subjects of childbearing potential and their partners must voluntarily use effective contraceptive methods during the study and continue for 6 months after the final dose; Note: Women of childbearing potential are those who have not undergone sterilization and either have not yet experienced menopause, have experienced menopause for less than 1 year, or have been menopausal for 1 year or more but have pathological conditions affecting menopause. Such women are considered to have potential fertility.\n  7. Subjects must voluntarily sign the informed consent before any study-related procedures begin, be able to communicate effectively with the investigator, and understand and agree to adhere strictly to the protocol requirements.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria should not be enrolled in this study:\n\n  1. Previous treatment with biological agents for Atopic dermatitis (e.g., dupilumab, tralokinumab), XKH001, or drugs with the same target (including investigational products);\n  2. Allergen-specific immunization therapy for Atopic dermatitis within 6 months prior to the first dose;\n  3. Systemic drug therapy for Atopic dermatitis within 4 weeks prior to the first dose:\n\n     Systemic corticosteroids (SCS); Immunosuppressants\u002Fimmunomodulators (e.g., cyclosporin, mycophenolate mofetil, interferon-γ (IFN-γ), Janus kinase (JAK) inhibitors, azathioprine, methotrexate); Traditional Chinese medicine (including modern Chinese medicine preparations) for Atopic dermatitis treatment;\n  4. Ultraviolet for Atopic dermatitis (including but not limited to narrow-band ultraviolet B (NB-UVB) and medium-to-high dose UVA1) within 4 weeks prior to the first dose;\n  5. Treatment with prescription emollients or emollients containing active ingedients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) initiated during the screening period (if such emollients are used prior to signing the informed consent, they can be continued at a stable dose);\n  6. ≥3 times of bleach bath therapy for Atopic dermatitis in any week within 4 weeks prior to the first dose;\n  7. The following topical drug therapy for Atopic dermatitis within 2 weeks prior to the first dose:\n\n     TCS or TCI; Other topical drugs: including but not limited to topical phosphodiesterase 4 (PDE-4) inhibitors (e.g., Crisaborole), JAK inhibitors (e.g., Ruxolitinib), traditional Chinese medicine (including modern Chinese medicine preparations);\n  8. Treatment with other biological agents within 5 half-lives (if known) or 16 weeks (whichever is longer) prior to the first dose;\n  9. Treatment with the investigational products (XKH001 or drugs with the same target, see Exclusion Criterion 1) or device therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the first dose.\n  10. Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (such as tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved\u002Fsubsided; or abnormally frequent, recurrent, or prolonged infections as determined by the investigator (Note: Confirmed\u002Fsuspected active or therapy naive latent TB must be excluded);\n  11. Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the first dose; or superficial skin infection within 1 week prior to the first dose (Note: Subjects can be re-screened after the infection has resolved);\n  12. Uncontrolled chronic diseases requiring extensive use of SCS, such as uncontrolled severe asthma (defined as ACQ-5 score ≥1.5 or history of ≥ 2 SCS use or hospitalization \\> 24 hours for asthmatic attack in the 12 months prior to signing the informed consent);\n  13. Laboratory test abnormal within 7 days prior to the first dose:\n\n      Hemoglobin (HGB) \\\u003C90 g\u002FL; Leukocyte count (WBC) \\\u003C3.0×109\u002FL; Absolute neutrophil count (ANC) \\\u003C1.5×109\u002FL; Platelet count (PLT) \\\u003C90×109\u002FL; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN); Bilirubin total (TBIL) \\> 1.5 ×ULN (subjects with Gilbert syndrome \\>3 × ULN); Creatinine clearance (CrCl) \\\u003C 50 mL\u002Fmin (Cockcroft-Gault formula);\n  14. Positive for hepatitis B surface antigen (HBsAg), or negative for HBsAg but positive for hepatitis B core antibody (HBcAb) and HBV-DNA \\> ULN, positive for antibody to hepatitis C virus (anti-HCV) and positive for HCV-RNA;\n  15. History of human immunodeficiency virus (HIV) infection or positive serum HIV antibody;\n  16. Other skin diseases that may interfere with the investigator's assessment during the screening period;\n  17. History of neoplasm malignant within 5 years prior to signing informed consent (except for cured squamous cell carcinoma of skin in situ and basal cell carcinoma, and cured cervical carcinoma in situ);\n  18. Diagnosed with active or suspected parasitic infection,, or at high risk of infection before the first administration: Unless clinical judgment (laboratory test assessment if necessary) has ruled out active infection;\n  19. Combined with various serious diseases that the investigator judges may affect the patient's participation in this study, including but not limited to: Diseases that seriously affect survival, uncontrolled diabetes mellitus, ≥ Grade 2 (CTCAE 5.0) dyslipidaemia of all types (attention should be paid to excluding the influence of physiological factors such as diet), New York Heart Association (NYHA) Class 3 to 4 cardiac insufficiency, renal insufficiency requiring dialysis, Child-Pugh Class B\u002FC liver function, demyelination diseases, active autoimmune diseases;\n  20. History of mental disorder; Individuals with a history of significant mental health disorders that may affect their ability to comply with the study requirements; in addition, patients with severe anxiety or depression or suicidal ideology\u002Fbehavior in the preceding 6 months will be excluded;\n  21. History of alcohol abuse or various drug abuse within 2 years prior to signing informed consent;\n  22. Vaccinated with attenuated live\u002Flive vaccine (including investigational vaccines) within 12 weeks prior to the first administration, or planning to be vaccinated with attenuated live\u002Flive vaccine during the study;\n  23. Major surgery (craniotomy, thoracotomy, laparotomy, etc.) within 4 weeks prior to the first administration, or planning to undergo major surgery during the study;\n  24. Within 2 weeks prior to the first administration, there is severe blood loss (total blood volume ≥ 500 mL), or received blood products, hematopoietic growth factors (e.g. granulocyte colony-stimulating factor G-CSF), albumin infusion;\n  25. Women who are known to be pregnant or have childbearing potential have a positive serum human chorionic gonadotropin (HCG) test at screening, or are breastfeeding, or are planning to become pregnant or breastfeed during the study;\n  26. Subjects with known allergy to the study drug, any ingredient in the study drug formulation, or history of allergy to protein drugs;\n  27. Other conditions that the investigator considers unsuitable for participation in this study;\n  28. Subjects who are currently enrolled in another clinical trial or investigational study",{"count":74,"type":22},120,[54],"This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.",[78],"Atopic Dermatitis",[78],"2025-06-27",{"date":82,"type":33},"2025-07-08",{"date":84,"type":22},"2025-08-31",{"date":86,"type":22},"2025-12-01",{"name":39,"class":40},""]