[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Institute Of Biological Products\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":347},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,50,80,105,124,148,171,193,213,238,258,278,303,326],{"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":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100620916","phase-1-phase-ibiia-clinical-trial-of-sibp-a16-injection-in-premature-infants-and-full-term-infants-100620916",false,"NCT07363837","Phase Ib\u002FIIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants","A Randomized, Double-blind, Placebo\u002FPositive Control, Dose-finding Phase Ib\u002FIIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants","Inclusion Criteria:\n\n* During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to \\\u003C35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;\n* Infants with a body weight ≥3 kg at screening;\n* Infants who are entering their first RSV infection season at screening;\n* Parents\u002Flegal guardians of trial participants have signed the informed consent form;\n* Parents\u002Flegal guardians of trial participants are able to understand and comply with the requirements and procedures of the protocol, including scheduled center visits, telephone interviews, and blood sample collection;\n* Participants can complete the follow-up period, which is approximately 1 year after the administration of the study drug.\n\nExclusion Criteria:\n\n* Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;\n* Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;\n* Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;\n* Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;\n* Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;\n* Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;\n* Participants who have received any medication within 7 days prior to drug administration, except for: a) various vitamins and iron supplements; b) systemic over-the-counter medications (such as analgesics) for common pediatric symptoms, which may be used occasionally, as determined by the investigator;\n* Participants with autoimmune diseases who are currently receiving, or are expected to receive according to the investigator's judgment, immunosuppressive therapy (including steroids, excluding topical steroids) during the trial period;\n* Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;\n* Known renal dysfunction or liver dysfunction;\n* Known to have chronic lung disease (CLD)\u002Fbronchopulmonary dysplasia;\n* Congenital respiratory abnormalities with clinical significance;\n* Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;\n* Suffering from chronic epilepsy or progressive or unstable neurological disorders;\n* Those who have previously experienced or are suspected to have experienced life-threatening acute events, and are still deemed unsuitable for participating in clinical trials by the researchers;\n* Known immune deficiency, including infection with human immunodeficiency virus (HIV);\n* The mother is infected with HIV (unless it has been proven that the trial participant is not infected);\n* The mother received the RSV vaccine during pregnancy;\n* Have received any investigational drugs or participated in any intervention studies;\n* Any other circumstances that the researcher believes may interfere with the evaluation of the study drug or the interpretation of the study results;\n* The participants are the children of the researchers, their subordinate researchers, relatives, or staff members of the sponsor.",true,"ALL","0 Months","12 Months",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This trial employs a randomized, double-blind, placebo\u002Fpositive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.",[29],"Respiratory Syncytial Virus (RSV)",[31,32,33,34,35,36],"RSV","Preliminary efficacy","Premature and term infants","Pharmacokinetics","Safety","Tolerability","NOT_YET_RECRUITING","2026-01-14",{"date":40,"type":41},"2026-01-23","ACTUAL",{"date":43,"type":22},"2026-01-15",{"date":45,"type":22},"2027-03-31",{"name":47,"class":48},"Shanghai Institute Of Biological Products","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100531043","phase-2-clinical-trial-of-sibp-03-in-patients-with-head-and-neck-squamous-cell-carcinoma-100531043","NCT06194656","Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent\u002FMetastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)","Inclusion Criteria:\n\n* The subjects voluntarily participated in the study and signed the informed consent.\n* Male and female aged between 18 and 75 years old, regardless of gender.\n* Patients with recurrent\u002Fmetastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1\u002Fanti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.\n* During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.\n* There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not measurable lesions unless the lesion has definite progression.\n* The ECOG physical fitness score is 0-1.\n* The laboratory test results meet the requirements.\n* The expected survival time is ≥ 3 months.\n* In fertile female subjects, the blood pregnancy test must be negative within 7 days before the first medication. Subjects of reproductive age (including male subjects) had no family planning during the trial period and within 6 months after the last administration and voluntarily took effective contraceptive measures.\n\nExclusion Criteria:\n\n* The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.\n* The participant has received any HER3 targeting or EGFR targeting therapy in the past.\n* Active central nervous system metastasis and\u002For meningeal metastasis.\n* Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.\n* In the past 5 years, the subjects had suffered from malignant tumors other than those treated in this study (except cured thyroid cancer, skin basal cell carcinoma and cervical carcinoma in situ).\n* People infected with active human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B vrius (HBV), syphilis or active tuberculosis, and asymptomatic chronic hepatitis B or hepatitis C carriers may be excluded.\n* The subjects have not recovered from the toxicity of previous anti-tumor therapy to grade ≤ 1 or baseline level (except participants with hair loss, neuropathy of grade ≤ 2 or stabilized thyroid function's decline by hormon replacement therapy).\n* Subjects are currently participating in and receiving research treatment or have been treated with other research drugs or medical devices within 4 weeks before the first use of research drugs.\n* Patients who plan to receive any other anti-tumor treatment during the trial should be excluded.\n* Major surgery, radiotherapy (except palliative radiotherapy for targeted bone metastasis), or treatment such as unhealed surgical wound, ulcer or fracture within 4 weeks before the first administration; Received Chinese patent medicines or Chinese herbal medicines with anti-tumor indications within 2 weeks before the first administration; Chemotherapy was received within 3 weeks before the first administration, and anti-tumor treatments such as biotherapy, endocrine therapy, targeted therapy and immunotherapy were received within 4 weeks\n* Those who have been vaccinated live within 30 days before the first administration.\n* Active infections requiring systemic treatment, such as pneumonia, bacteremia, septicemia, etc.\n* A history of pulmonary interstitial disease, pulmonary interstitial fibrosis or drug-induced interstitial pneumonia or other clinically serious lung diseases (CTCAE 5.0 grade III-IV).\n* Pulmonary thromboembolism, arterial thrombosis and deep vein thrombosis formation (DVT) occurred within 6 months before screening, except for infusion set-related thrombosis.\n* Have a history or evidence of cardiovascular (CV) risk.\n* During the screening period, 12-lead electrocardiogram (ECG) measurement was performed in the research center (the average value of QTcF that needs to be measured repeatedly for 3 times), and the QT interval (QTcF) corrected by Fridericia method was \\> 450 milliseconds (male) or (QTcF) \\> 470 milliseconds (female); LVEF of cardiac ultrasound was less than 50%.\n* Therapeutic surgery was performed within 28 days before the first administration, or major surgery was expected during the study period (except diagnosis, biopsy and drainage).\n* People with mental disorders or poor compliance.\n* Pregnant or lactating women.\n* According to the researcher's judgment, there are accompanying diseases (such as severe hypertension, diabetes, thyroid diseases, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.\n* Suffering from diseases requiring long-term treatment with high doses (defined as 30mg\u002Fd hydrocortisone or equivalent doses of other hormonal drugs) of hormones or immunosuppressive drugs.\n* After active treatment, uncontrollable pleural and abdominal cavity or other lacunar effusion.","18 Years","75 Years",{"count":60,"type":22},81,[26],"This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.",[64],"Head and Neck Squamous Cell Carcinoma",[66,67,68,69,70],"Head and neck squamous cell carcinoma","safety","tolerability","pharmacokinetics","efficacy","RECRUITING",{"date":73,"type":41},"2026-01-16",{"date":75,"type":41},"2024-09-27",{"date":77,"type":22},"2026-07-30",{"name":47,"class":48},2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":16,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":79},"100618113","phase-2-phase--clinical-trial-of-influenza-virus-split-vaccine-for-individuals-aged-60-years-and-above-100618113","NCT07327398","Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above","A Randomized, Double-blind, Active-controlled Phase Ⅱ Clinical Trial to Evaluate the Immunogenicity and Safety of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above","Inclusion Criteria:\n\n* Age over 60 years old, gender not limited, and able to provide legal identification;\n* Volunteers voluntarily participate in the study and sign an informed consent form;\n* Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.\n\nExclusion Criteria:\n\n* On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;\n* Those who have had influenza in the past 6 months or meet the definition of influenza like cases;\n* Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;\n* Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine\u002Fdrug, or history of asthma;\n* Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;\n* Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;\n* Have received any vaccine within 2 weeks prior to vaccination;\n* Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;\n* Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;\n* Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;\n* Have received blood or blood related products within the past 6 months;\n* Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;\n* Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;\n* Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;\n* Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;\n* Currently or recently planning to participate in other clinical trials;\n* Researchers determine any situation that is not suitable for clinical trials.","60 Years",{"count":89,"type":22},1200,[26],"To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL\u002Fdose) to individuals aged 60 and above.",[93],"Influenza",[95,35,96,97],"Influenza virus split vaccine","Immunogenicity","The elderly","2026-01-13",{"date":43,"type":41},{"date":101,"type":22},"2026-01-07",{"date":103,"type":22},"2026-09-30",{"name":47,"class":48},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":16,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":49},"100616180","phase-1-a-clinical-trial-of-influenza-virus-split-vaccine-for-individuals-aged-60-years-and-above-100616180","NCT07302256","A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above","A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above","Inclusion Criteria:\n\n* Age over 60 years old, gender not limited, and able to provide legal identification;\n* Volunteers voluntarily participate in the study and sign an informed consent form;\n* Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.\n\nExclusion Criteria:\n\n* On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;\n* Those who have had influenza in the past 6 months or meet the definition of influenza like cases;\n* Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;\n* Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine\u002Fdrug, or history of asthma;\n* Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;\n* Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;\n* Have received any vaccine within 2 weeks prior to vaccination;\n* Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;\n* Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;\n* Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;\n* Have received blood or blood related products within the past 6 months;\n* Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;\n* Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;\n* Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;\n* Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;\n* Currently or recently planning to participate in other clinical trials;\n* Abnormal laboratory test indicators before vaccination;\n* Researchers determine any situation that is not suitable for clinical trials.",{"count":113,"type":22},120,[25],"This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL\u002Fvial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.",[93],[95,97,96,35],{"date":38,"type":41},{"date":120,"type":41},"2025-12-16",{"date":122,"type":22},"2026-08-31",{"name":47,"class":48},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":49},"100608718","phase-1-a-clinical-trial-of-sibp-a10-injection-in-the-treatment-of-advanced-malignant-tumor-subjects-100608718","NCT07205198","A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects","Inclusion Criteria:\n\n* Voluntarily participate in this study and sign an informed consent form;\n* Age range of 18 to 75 years old (including boundary values), gender not limited;\n* The clinical diagnosis of enrolled subjects should meet the conditions specified in the protocol:\n* There must be at least one measurable lesion as the target lesion;\n* Backfilling queue during dose escalation stage, dose expansion stage, and indication expansion stage: able to provide tumor tissue samples that meet the requirements of the protocol or undergo tumor biopsy during screening, or provide testing reports issued by legitimate testing institutions that meet the requirements;\n* I have not received any medication targeting Siglec-15 in the past;\n* The Eastern Cooperative Oncology Group (ECOG) physical fitness score ranges from 0 to 1;\n* Expected survival period ≥ 3 months;\n* During the screening period, the main organ functions were basically normal;\n* During the screening period, women of childbearing age had negative blood pregnancy tests, and reproductive age subjects (including male subjects) had no pregnancy plans during the trial period and within 6 months after the last dose, and voluntarily took effective contraceptive measures.\n\nExclusion Criteria:\n\n* The subject has the following tumors:\n\n  * The subject has had other malignant tumors that have not healed within the past 5 years;\n  * Subjects with meningeal metastases;\n  * Subjects with active brain metastases;\n* For anti-tumor subjects with a history of past treatment or surgery that does not comply with the protocol, or who have received treatment that does not comply with the protocol during the planned trial period\n* Previous medical history or laboratory non-compliance with protocol requirements\n* According to the researchers' assessment, the screening period is accompanied by severe, progressive, or uncontrolled non-tumor diseases, and it has been determined by the researchers that participating in the study would increase the risk for the subjects.\n* According to the investigator's judgment, there are concomitant diseases (including but not limited to hypertension, diabetes, active infection, etc. that cannot be controlled by drugs) that seriously endanger the patient's safety or affect the patient's completion of the study\n* Researchers determine that there are uncontrollable ascites, pleural effusion, or pericardial effusion, or those who have undergone ≥ 2 serosal drainage within 2 weeks prior to the first administration;\n* Before starting treatment, the patient has not yet recovered to ≤ grade 1 from the toxic effects of previous treatments (including previous immunotherapy) and\u002For complications of previous surgical interventions.\n* Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug;\n* Pregnant and lactating women;\n* Researchers believe that subjects who are not suitable to participate in this clinical study due to other reasons.",{"count":132,"type":22},160,[25],"To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).",[136],"Advanced Tumors",[138,139,67,70,69],"Advanced malignant tumor","SIBP-A10","2026-01-06",{"date":142,"type":41},"2026-01-08",{"date":144,"type":41},"2025-10-31",{"date":146,"type":22},"2028-12-30",{"name":47,"class":48},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":49},"100592210","phase-1-a-clinical-trial-of-sibp-a19-injection-in-the-treatment-of-advanced-malignant-solid-tumor-patients-100592210","NCT06990464","A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","Inclusion Criteria:\n\n* Age range from 18 to 75 years old (including boundary values), regardless of gender.\n* Voluntarily participate in this study and sign the informed consent form.\n* Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance.\n* Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements.\n* There must be at least one measurable lesion as the target lesion.\n* ECOG score 0-1.\n* Expected survival time ≥ 3 months.\n* During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug):\n\n  • Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9\u002FL, platelet (PLT) count\n\n  ≥ 90 × 10 9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n* Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.\n\nExclusion Criteria:\n\n* Participants with the following tumors:\n\n  * The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).\n  * The participant has untreated imaging confirmed central nervous system metastasis.\n  * Meningeal metastases.\n  * Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.\n* Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:\n\n  * Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;\n  * Patients undergoing adjuvant therapy within 6 months after surgery;\n  * Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);\n  * Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs.\n  * Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients).\n  * The dose (prednisone\\>10 mg\u002Fd or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.\n* Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:\n\n  * Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration.\n  * Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n  * Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n  * Known history of drug abuse, alcoholism, or drug use that may affect the results of the trial.\n* According to the investigator's judgment, the screening period is accompanied by serious, progressive, or uncontrolled diseases, and the investigator's assessment determines that the participant's participation in the study will increase the risk.\n* According to the investigator's judgment, there are serious accompanying diseases that pose a threat to patient safety or affect the completion of the study.\n* Patients with uncontrolled ascites, pleural effusion, pericardial effusion during the screening period or those who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first administration.\n* Patients who must take supplements containing folic acid (such as those with folate deficiency).\n* Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug.\n* Pregnant and lactating women.\n* Patients who are deemed unsuitable to participate in this clinical study due to other reasons by the investigators.",{"count":156,"type":22},156,[25],"To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).",[160],"Advanced Solid Tumors",[162,163,35,164,34],"Advanced solid tumor","ADC","Efficacy",{"date":142,"type":41},{"date":167,"type":41},"2025-06-11",{"date":169,"type":22},"2028-12-15",{"name":47,"class":48},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":49},"100538994","phase-1-a-phase-ib-clinical-trial-of-peguricase-for-injection-with-methotrexate-in-patients-with-uncontrolled-gout-100538994","NCT06298071","A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.","A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics, and Initial Efficacy of Single and Multiple Dosing of Peguricase for Injection With Methotrexate in Patients With Gout.","Inclusion Criteria:\n\n* Willing and able to give informed consent.\n* Male and female aged between 18 and 70 years old , regardless of gender.\n* Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg\u002Fm2 (including 19 and 30)；\n* The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol\u002FL at screening；\n* Patients whose serum uric acid level could not reach the target after standard treatment with conventional uric acid-lowering drugs or who were contraindicated or intolerant to conventional uric acid-lowering drugs；\n* Patients who were willing to stop taking any uric-acid-lowering drug at least 7 days before using methotrexate during the run-in period;\n* Could tolerate the prescribed dose of methotrexate during the run-in period;\n* Patients were able to attend and complete the visit on time.\n\nExclusion Criteria:\n\n* Patients had active systemic infection within 2 weeks before enrollment，including an infection for which treatment was being received；\n* Having a chronic or recurrent infection, such as recurrent pneumonia or chronic bronchitis; Patients with active or severe lung disease or pulmonary insufficiency on chest imaging, or current pulmonary fibrosis or bronchiectasis；\n* Patients who are on anti-TB treatment or have active TB；\n* Diagnosis of osteomyelitis；\n* Ongoing or long-term use of immune system modulating drugs, such as methotrexate, mercaptopurine, mycophanolate, long-term use (≥3 months) of prednisone ≥10 mg\u002F day or equivalent dose of corticosteroids; Or have a history of transplant surgery requiring long-term immunotherapy; Or a known history of autoimmune disease, allergic disease;\n* Known allergy to recombinant proteins or porcine products, or history of allergy to uricase, pegylated products, corticosteroids and antihistamines, or known intolerance to methotrexate, fexofenadine, acetaminophen or contraindications to methotrexate, fexofenadine, acetaminophen;\n* Patients who are known to be intolerant to all gout attack management regiments (participants must be able to tolerate at least one: Colchicine and\u002For Nsaids and\u002For Prednisone 0.5 mg\u002Fkg daily；\n* Patients who have previously been treated with pegyluricase or other recombinant uricase, or who have been treated with other pegylated biological products;\n* Participation in other clinical study with a drug intervention within 4 weeks before initiation of methotrexate or the drug was still in the elimination phase before screening (within 5 half-lives), whichever is older;\n* Patients with chronic liver disease such as hepatitis, cirrhosis, alcoholic liver disease;\n* Patients have unstable angina, severe arrhythmias requiring drug intervention, congestive heart failure (NYHA grade≥Ⅱ), uncontrolled hypertension (over 150\u002F95 mmHg), poor glycemic control in diabetics ( HbA1c≥7%), acute stroke, Severe or chronic hemorrhagic digestive disease, pleural and abdominal effusion;\n* A history of hypoxanthine-guanine phosphoribosyltransferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome;\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD test values below the lower limit of normal;\n* Estimated glomerular filtration rate (eGFR) ≤40 mL\u002Fmin\u002F1.73m2, or currently receiving dialysis, or end-stage renal disease (CKD4-5);\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal value or albumin below the lower limit of normal value during screening (before methotrexate treatment);\n* Use of any blood component, short-acting or long-acting growth factor drugs within 14 days prior to screening, or white blood cell count \\\u003C 4×109\u002FL, hematopoietic volume \\\u003C 32%, or platelet count \\\u003C 75×109\u002FL;\n* Receiving anticoagulant therapy or international normalized ratio (INR) \\> 1.5×ULN or activated partial thromboplastin time (APTT) \\> 1.5×ULN before enrollment;\n* Receiving systemic or local radiotherapy for tumors, or history of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix;\n* Any acute illness that was considered by the investigator to be likely to affect the study occurred within 1 month before screening;\n* Donated (or lost) blood and donated (or lost) ≥400 mL or received blood transfusion within 3 months before screening;\n* If any one of the five serological tests of hepatitis B was positive except for hepatitis B surface antibody, or hepatitis C antibody positive, treponema pallidum antibody positive or HIV antibody positive in serum virology examination;\n* History of drug or substance abuse, or a positive drug screening test;\n* History of alcohol abuse in the 3 months before screening \\[drinking more than 14 units of alcohol per week (1 unit ≈360 mL of beer)\\] or 45 mL of 40% spirits or 150 mL of wine)\\]; or positive alcohol breath test on admission;\n* Lactating women, as well as male participants (or their partners) or female participants 30 days before the study to the end of the study, who have plans for pregnancy or sperm or egg donation within 6 months and are unwilling to take effective contraceptive measures;\n* Patients have serious mental and psychological disorders, cognitive disorders and the existence of a history of mental illness.\n* The investigator considered it inappropriate to participate in the study.","70 Years",{"count":21,"type":22},[25],"To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.",[183],"Gout",[185,186,35,36,164],"Uncontrolled gout","Peguricase for injection",{"date":142,"type":41},{"date":189,"type":41},"2023-03-03",{"date":191,"type":22},"2026-12-30",{"name":47,"class":48},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":49},"100591818","phase-1-a-clinical-trial-of-sibp-a18-injection-in-the-treatment-of-advanced-malignant-solid-tumor-patients-100591818","NCT06985368","A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","Inclusion Criteria:\n\n* Age range from 18 to 75 years old (including boundary values), regardless of gender.\n* The clinical diagnosis of enrolled participants should meet the following criteria:\n\n  1. Dose escalation and dose expansion stage: Patients with advanced solid tumor diagnosed by histology and\u002For cytology, who have previously failed standard treatment, lack standard treatment regimens, are intolerant to standard treatment, or are currently not eligible for standard treatment.\n  2. Indications expansion stage:\n\nQueue 1: CLDN18.2 positive late stage gastric cancer\u002Fgastroesophageal junction cancer (GC\u002FGEJC) confirmed by histology or cytology with standard treatment failure, intolerance, or no standard treatment.\n\nQueue 2: Late stage CLDN18.2 positive PC confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.\n\nQueue 3: CLDN18.2 positive late biliary tract cancer (BTC) confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.\n\n* Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.\n* At least one measurable lesion must be selected as the target lesion (according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).\n* The patient has not previously received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates\n* ECOG score 0-1.\n* Expected survival time ≥ 3 months.\n* During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug):\n\nBlood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10\\^9\u002FL, platelet (PLT) count\n\n≥ 90 × 10 9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n\n* Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.\n* Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Participants with the following tumors:\n\n  * The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).\n  * The participant has untreated imaging confirmed central nervous system metastasis.\n  * Meningeal metastases.\n  * Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.\n* Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:\n\n  * Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;\n  * Patients undergoing adjuvant therapy within 6 months after surgery;\n  * Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);\n  * Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs.\n  * Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients).\n  * The dose (prednisone\\>10 mg\u002Fd or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.\n* Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:\n\nIndividuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration.\n\n* Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n\n  * Screening period for syphilis spiral antibody positive individuals; Individuals with active hepatitis B virus (HBV) and hepatitis C virus (HCV) infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment.\n  * Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration.\n  * The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk. Including but not limited to:\n* Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of cardiac or renal dysfunction ≥ Level II.\n\n  * According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.\n\n    1. Hypertension that cannot be controlled clinically.\n    2. Diabetes with poor drug control.\n    3. Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.\n    4. Serious infections that occurred within 4 weeks prior to initiating research treatment.\n  * Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug.\n  * Pregnant and lactating women.\n  * Patients deemed unsuitable for inclusion by researchers.",{"count":156,"type":22},[25],"The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).\n\nA secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval\u002FCorrected QT interval (QT\u002FQTc interval) in participants with advanced solid tumors",[204],"Solid Tumor Malignancy",[204,163,35,164,34],"2026-01-05",{"date":101,"type":41},{"date":209,"type":41},"2025-06-16",{"date":211,"type":22},"2028-09-15",{"name":47,"class":48},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":16,"sex":17,"minAge":220,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":49},"100587756","phase-1-a-study-to-evaluate-the-safety-of-recombinant-herpes-zoster-vaccine-for-healthy-individuals-100587756","NCT06932523","A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals","Randomized, Blinded, Controlled Phase I\u002FⅡ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above","Inclusion Criteria:\n\n* Age ≥ 40 years old on the day of enrollment, gender not limited.\n* Can provide legal proof of identity.\n* Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.\n* Be able to participate in all planned follow-up visits and comply with all trial procedures.\n* On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).\n* Chronic disease patients need to be in a stable period of chronic disease.\n* Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption.\n\nExclusion Criteria:\n\n* Individuals with a history of herpes zoster in the past.\n* Individuals with a history of vaccination against chickenpox or shingles.\n* Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.\n* Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.\n* Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.\n* Use immunoglobulin and\u002For any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period.\n* Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine.\n* Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period.\n* Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine.\n* Suffering from a serious illness that prevents the completion of the entire experiment.\n* Received immunosuppressive therapy or other immunomodulatory drugs, monoclonal antibodies, thymosin, interferon, etc. within 6 months prior to vaccination with the experimental vaccine, or planned to receive such treatment within 1 month after the first dose to full immunization, but local medication is allowed.\n* Chemotherapy, radiotherapy, and organ and bone marrow transplantation related treatments for cancer or other diseases.\n* Diseases or medical measures that lead to immune dysfunction\n* Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis.\n* Moderate or severe acute illness\u002Finfection, or febrile illness within 72 hours prior to vaccination.\n* Known to have a history of thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants.\n* Suffering from serious cardiovascular disease, pulmonary edema, serious liver and kidney disease, and diabetes that cannot be controlled by drugs.\n* Previous history of mental and neurological disorders or family history of mental illness.\n* Currently suffering from various severe infectious, suppurative, and allergic skin diseases.\n* Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit.\n* (Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urine routine indicators before vaccination (excluding those judged by doctors to have no clinical significance).\n* Any situation that the researcher believes may affect the evaluation of the experiment.","40 Years",{"count":222,"type":22},645,[25,26],"The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).",[226],"Herpes Zoster (HZ)",[228,229,230,67,231],"herpes zoster","recombinant herpes zoster vaccine","vaccine","immunogenicity",{"date":101,"type":41},{"date":234,"type":41},"2025-04-04",{"date":236,"type":22},"2027-12-31",{"name":47,"class":48},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":49},"100555440","phase-1-a-clinical-trial-of-sibp-a17-injection-in-the-treatment-of-advanced-solid-tumor-patients-100555440","NCT06512116","A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.","An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of SIBP-A17 Formulation for Injection in Subjects With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Age range of 18 to 75 years old (including boundary values), gender not limited.\n* The clinical diagnosis of enrolled subjects should meet the following criteria:\n\n  1. Dose escalation stage:\n\n     Advanced solid tumor subjects confirmed by histology or cytology to have no standard treatment plan or ineffective or intolerant standard treatment plan.\n  2. Dose expansion stage:\n\n     * Cohort 1: Late\u002Funresectable and\u002For metastatic breast cancer with low HER2 expression (IHC1+or IHC2+\u002FFISH -) after standard treatment failure or intolerance.\n     * Cohort 2: HER2 positive (IHC3+or IHC2+and FISH+) local advanced or metastatic digestive system tumors that fail or are not tolerated after standard treatment, including adenocarcinoma of stomach or gastroesophageal junction, colorectal cancer, etc. (pancreatic cancer and biliary tract cancer are excluded).\n     * Cohort 3: HER2 positive (IHC3+or IHC2+with FISH+) advanced gynecological tumors that have failed or are intolerant to standard treatment, including but not limited to cervical cancer, endometrial cancer, and ovarian cancer.\n     * Cohort 4: Other advanced solid tumors with HER2 expression that failed or were intolerant after standard treatment were preferentially included but not limited to HER2 positive (IHC3+or IHC2+and FISH+) breast cancer (at least 10 cases included), non-small cell lung cancer, etc.\n* Willing and able to provide sufficient fresh collected or archived tumor tissue samples (only applicable during dose expansion phase).\n* There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 criteria, CT or MRI). Lesions that have received previous radiotherapy or other local treatments are not considered as target lesions unless there is clear progression of the lesion.\n* The Eastern Cooperative Oncology Group (ECOG) score for physical fitness is 0 or Expected survival period ≥ 3 months.\n* During the screening period, the main organ functions were basically normal \\[no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the experimental drug\\]\n* During the screening period, women of childbearing age with negative blood pregnancy test results and reproductive age subjects (including male subjects) who have no pregnancy plans during the trial period and within 6 months after the last dose and voluntarily take effective contraceptive measures.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with tumors as specified in the protocol\n* Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.\n* Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.\n* Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).\n* Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first administration.\n* The screening period is accompanied by severe, progressive, or uncontrolled diseases, and it has been assessed by the researchers that participation in the study would increase the risk for the subjects.\n* History of interstitial lung disease\u002Fnon infectious pneumonia in the past, currently suffering from interstitial lung disease\u002Fnon infectious pneumonia, or suspected interstitial lung disease\u002Fnon infectious pneumonia that cannot be excluded through imaging examination during screening.\n* Subjects who have experienced severe infections within 4 weeks prior to their first medication. Active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first medication. Subjects receiving prophylactic antibiotic treatment can be enrolled.\n* Participants who have participated in any clinical trial as subjects within the first 3 months of enrollment (excluding subjects who have only participated in clinical trial screening and have not used the investigational drug).\n* According to the judgment of the investigator, there are concomitant diseases (such as severe diabetes, thyroid disease, etc.) that seriously endanger the safety of the subject or affect the completion of the study.\n* Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug.\n* Pregnant and lactating women.\n* Researchers believe that participants who are not suitable for enrollment.",{"count":246,"type":22},196,[25],"To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).",[250],"Advanced Solid Tumor",[162,252,35,164,34],"Her2-ADC",{"date":101,"type":41},{"date":255,"type":41},"2024-07-23",{"date":191,"type":22},{"name":47,"class":48},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":49},"100538993","phase-1-a-clinical-trial-of-sibp-a13-injection-in-the-treatment-of-advanced-malignant-solid-tumor-patients-100538993","NCT06298058","A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.","A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.","Inclusion Criteria:\n\n* Age range from 18 to 75 years old (including boundary values), regardless of gender.\n* The clinical diagnosis of enrolled participants should meet the following criteria:\n\n  1. Dose escalation and dose expansion stage: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology and judged by the researcher to be unable to benefit from available standard treatment, or intolerant.\n  2. Indications expansion stage:\n\n     * Queue 1: Non-small cell lung cancer (NSCLC) confirmed by histology or cytology, with disease progression and EGFR mutation during or after treatment with third generation TKI and platinum containing therapy.\n     * Queue 2: Breast cancer (BC) confirmed as HER3 positive by histology or cytology after standard treatment failure.\n     * Queue 3: Patients with recurrent\u002Fmetastatic advanced HNSCC confirmed by histology or cytology, unsuitable for radical surgical resection, and standard treatment failure.\n* At least one measurable lesion must be selected as the target lesion (according to RECIST v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).\n* The patient has not previously used anti-HER3 antibodies or other HER3 targeted treatments (such as Deparezumab (HER3-DXd).\n* Drugs that have not received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates (ADCs) .\n* ECOG score 0-1.\n* Expected survival time ≥ 3 months.\n* During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug):\n\nBlood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9\u002FL, platelet (PLT) count ≥ 90 × 10 9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n\n* Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.\n* Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Participants with the following tumors:\n\n  * The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).\n  * The participant has untreated imaging confirmed central nervous system metastasis.\n  * Meningeal metastases.\n  * Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.\n* Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:\n\n  * Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;\n  * Patients undergoing adjuvant therapy within 6 months after surgery;\n  * Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);\n  * Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs.\n  * Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients).\n  * The dose (prednisone\\>10 mg\u002Fd or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.\n* Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:\n\n  * Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration.\n  * Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n  * Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n* Screening period for syphilis spiral antibody positive individuals; Individuals with active HBV and HCV infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment.\n* Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration.\n* The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk. Including but not limited to:\n\n  * Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of cardiac or renal dysfunction ≥ Level II.\n* According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.\n\n  1. Hypertension that cannot be controlled clinically.\n  2. Diabetes with poor drug control.\n  3. Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.\n  4. Serious infections that occurred within 4 weeks prior to initiating research treatment.\n* Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug.\n* Pregnant and lactating women.\n* Patients deemed unsuitable for inclusion by researchers.",{"count":266,"type":22},144,[25],"To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).",[250],[162,271,35,164,34],"Her3-ADC",{"date":101,"type":41},{"date":274,"type":41},"2024-05-09",{"date":276,"type":22},"2026-06-30",{"name":47,"class":48},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":16,"sex":17,"minAge":285,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100612445","phase-2-evaluate-the-safety-and-immunogenicity-of-the-mva-sibp-vaccine-in-the-democratic-republic-of-the-congo-100612445","NCT07253675","Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo","Phase 2 Double-Blind, Randomized, Controlled Study of MVA-SIBP Vaccine for Mpox in Age De-escalation in the Democratic Republic of the Congo","Inclusion Criteria:\n\n* Adults: 18 to 45 years inclusive at the time of informed consent. Adolescents: 12 to 17 years inclusive at the time of consent\u002Fassent. Children: 2 to 11 years inclusive at the time of consent\u002Fassent.\n* Participant is in good general health as determined by medical history, targeted physical examination, and clinical judgment of the investigator.\n* Adults: Able to read and understand the written informed consent, and willing to comply with all study procedures and availability for the entire study duration. Adolescents: Parent(s) or legally acceptable representative(s) able and willing to provide written informed consent; participant able and willing to provide appropriate assent per local regulations and IRB requirements. Children: Parent(s) or legally acceptable representative(s), with the relationship to the child similarly verified and documented on the consent form, and able and willing to provide written informed consent.\n* Willing and able to comply with all study procedures, visit schedule, and follow-up requirements as judged by the investigator.\n* No history of smallpox or mpox vaccination. No history of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.\n* Negative serum or urine pregnancy test at screening and prior to each vaccination. Willing to use highly effective contraception from 30 days prior to first vaccination through 60 days after the last dose. Breastfeeding.\n* Resides in the study catchment area and has no plans to relocate for the duration of the study. Has reliable access to a telephone and\u002For other means of contact.\n* Adults must have been born in 1980 or later. Able to provide direct written informed consent.\n* Adolescents: Able to provide written or written assent as appropriate. Children: Parent(s)\u002Fguardian(s) able to provide written informed consent; child able to provide assent if developmentally appropriate.\n\nExclusion Criteria:\n\n* Any prior smallpox or mpox vaccination. History of confirmed or suspected infection with monkeypox, cowpox, or vaccinia virus.\n* Close contact, as defined by WHO.\n* Known or suspected immunocompromised state as specified in the protocol.\n* Acute febrile illness (≥38.0°C) or clinically significant infection within 72 hours prior to vaccination. Any acute illness requiring systemic therapy or hospitalization within 14 days prior to enrollment.\n* History of severe allergy or anaphylaxis to any vaccine or vaccine component. History of severe allergic asthma or asthmatic reactions.\n* Pregnant or breastfeeding at screening or planning to become pregnant during the study period.\n* Participation in another clinical trial with an investigational product or vaccine within 6 months prior to enrollment or planned during the study.\n* Receipt of any live vaccine within 28 days or inactivated vaccine within 14 days prior to enrollment or planned within 28 days after any study vaccination.\n* Any medical disease or condition that, in the opinion of the investigator, would place the participant at unacceptable risk, interfere with study objectives, or compromise protocol compliance.\n* Blood transfusion within three months before inclusion. Significant laboratory test result abnormalities should be added as exclusion criteria. Any condition that, in the opinion of the investigator, would preclude safe participation or successful completion of the study.","2 Years","45 Years",{"count":288,"type":22},180,[26],"To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).",[292],"Monkeypox (Mpox)",[294,230,67,231],"Monkeypox","2025-11-19",{"date":297,"type":41},"2025-11-28",{"date":299,"type":22},"2025-12-31",{"date":301,"type":22},"2027-02-28",{"name":47,"class":48},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":286,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":49},"100601163","early-phase-1-a-clinical-trial-of-sibp-a16-injection-in-healthy-adults-100601163","NCT07106918","A Clinical Trial of SIBP-A16 Injection in Healthy Adults","A Randomized, Double-blind, Placebo\u002FPositive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Healthy Adults","Inclusion Criteria:\n\n* Healthy individuals aged 18 to 45 on the day of enrollment, regardless of gender.\n* Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, BMI between 19.0 and 27.0 kg\u002Fm2 (including critical values).\n* Screening period physical examination, vital sign examination, 12 lead electrocardiogram, chest X-ray or clinical laboratory examination, and other auxiliary examination results show normal or abnormal without clinical significance as judged by the researcher.\n* Individuals who voluntarily participate in clinical trials and sign informed consent forms.\n* Individuals are able to communicate well with the researchers and understand and comply with the requirements of this study.\n\nExclusion Criteria:\n\n* Known to have a history of serious clinical diseases such as mental system, circulatory system, endocrine system, digestive system, respiratory system, hematological and metabolic abnormalities, or any other diseases that can interfere with the test results.\n* Individuals with a history of drug allergies or specific allergies, or individuals with allergies, or those known to be allergic to the components or analogues of this drug.\n* During the screening period, individuals with abnormal results from physical examination, laboratory tests and clinical significance were identified by the researchers as having an impact on the evaluation of this trial.\n* During the screening period, male individuals with QTcF ≥ 450 milliseconds and female individuals with QTcF ≥ 470 milliseconds on electrocardiogram.\n* Individuals who have received monoclonal\u002Fpolyclonal antibody drugs within 6 months prior to screening.\n* Individuals have received immunoglobulin or blood product treatment within 6 months prior to screening.\n* Individuals who have received passive immune agents, immunosuppressants, or corticosteroids within the 6 months prior to screening.\n* Individuals who experience acute illnesses such as fever ≥ 37.3 ℃ (armpit temperature) and diarrhea within one week before their first medication.\n* Individuals experienced symptoms and signs of acute upper respiratory tract infection within 2 weeks prior to the first use of medication.\n* Individuals who have received the respiratory syncytial virus (RSV) vaccine in the past.\n* Individuals have received any vaccine within 30 days prior to screening.\n* Select individuals who have smoked at least 5 cigarettes per day within the first 3 months and those who cannot quit smoking throughout the entire trial period.\n* Individuals with an average weekly alcohol consumption of ≥ 14 units within the first 3 months of screening, or those who cannot abstain from alcohol during the trial period.\n* Individuals have a history of long-term excessive consumption of tea, coffee, or caffeinated beverages.\n* Individuals have used any medication or health supplement within the 14 days prior to screening.\n* Individuals with a history of drug abuse\u002Fdependence or drug use within the past year prior to screening.\n* Screening individuals who have participated in any drug clinical trials and have used the investigational drug within the previous 3 months.\n* Individuals with a history of blood donation or significant bleeding within the previous 4 weeks prior to screening, or those planning to donate blood or blood components during the study period.\n* Pregnant or lactating women.\n* Those who have plans to conceive, donate sperm or eggs, or are unable to voluntarily take effective contraceptive measures during the trial period (including partners).\n* Those who have special dietary requirements and cannot follow a reasonable and normal diet.\n* The researchers believe that the individuals may have other situations that may affect compliance or be unsuitable to participate in this trial",{"count":311,"type":22},140,[313],"EARLY_PHASE1","This study is a randomized, double-blind, placebo\u002Fpositive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults",[29],[317,318,67,68,69],"Respiratory syncytial virus","SIBP-A16",{"date":320,"type":41},"2025-11-25",{"date":322,"type":41},"2025-08-17",{"date":324,"type":22},"2027-04-30",{"name":47,"class":48},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":49},"100575376","phase-1-a-study-evaluating-the-safety-and-immunogenicity-of-mva-strain-monkeypox-attenuated-live-vaccine-100575376","NCT06771479","A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine","A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine for Individuals Aged 18 and Above","Inclusion Criteria:\n\n* On the day of enrollment, individuals aged 18 years or older with a history of smallpox vaccination must have been born before 1980;\n* Can provide legal proof of identity;\n* Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment;\n* Be able to participate in all planned follow-up visits and comply with all trial procedures (such as completing diary\u002Fcontact cards and being able to return for visits);\n* On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature);\n* Men and women of childbearing age who have no plans to have children within 6 months and agree to take effective contraceptive measures within 6 months after receiving the experimental vaccine.\n\nExclusion Criteria:\n\n* Individuals with a history of smallpox, monkeypox, or close contact with monkeypox in the past;\n* Individuals who are allergic to any ingredients of eggs, vaccines, or substances used in production processes, or have a history of other severe allergies;\n* Use immunoglobulin and\u002For any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period;\n* Currently using salicylate drugs or planning long-term use during the trial period;\n* Have used any experimental or unregistered products within one month prior to administering the trial vaccine, or plan to use them during the trial period;\n* Administer inactivated vaccine within 14 days before administering the experimental vaccine or attenuated live vaccine within 30 days before administering the experimental vaccine;\n* Chronic disease patients are in the acute or progressive phase of chronic disease;\n* Long term use of immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination with the experimental vaccine;\n* Having undergone chemotherapy or radiation therapy or organ and bone marrow transplantation related treatments for cancer or other diseases;\n* Diseases or medical measures that lead to immune dysfunction, such as congenital immunodeficiency, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or malignant tumors, etc;\n* Moderate or severe acute illness\u002Finfection, or febrile illness on the day of vaccination;\n* Individuals with a history of thrombocytopenia or other coagulation disorders may be contraindicated for subcutaneous injection;\n* Suffering from serious cardiovascular disease, serious liver and kidney disease, and diabetes that cannot be controlled by drugs;\n* Previous history of mental or neurological disorders or family history;\n* Currently suffering from various infectious, suppurative, and allergic skin diseases;\n* Women of childbearing age: pregnant or lactating, or with a positive blood pregnancy test;\n* Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit;\n* Abnormal blood routine, blood biochemistry, urine routine, electrocardiogram or heart disease related indicators before vaccination (except for minor abnormalities judged by doctors to have no clinical significance);\n* Researchers believe that any situation that may affect the evaluation of the experiment;\n* Active tuberculosis patients;\n* For HIV infected individuals, the plasma HIV-1 RNA level during screening should be ≥ 200 copies\u002FmL, or positive test for hepatitis B, hepatitis C and syphilis;\n* For healthy people and men and women who have sex with each other, hepatitis B, hepatitis C, syphilis and HIV) are positive;\n* Individuals who experience severe allergic reactions after the first dose of vaccination;\n* Serious adverse events that are definitely related to the first dose of vaccination;\n* For those who are newly discovered or occur after the first dose of vaccination and do not meet the inclusion criteria or the exclusion criteria for the first dose, the researcher shall determine whether to continue participating in the trial.",{"count":113,"type":22},[25],"This is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above.",[294],[338,67,230,231,294],"Monkeypox vaccine","2025-10-02",{"date":341,"type":41},"2025-10-03",{"date":343,"type":41},"2025-01-22",{"date":345,"type":22},"2026-05-30",{"name":47,"class":48},""]