北京呫诺美林/曲司氯铵胶囊III期临床试验-KarXT+KarX-EC 治疗阿尔茨海默病激越的开放标签扩展研究

登记号	CTR20262871	试验状态	进行中
申请人联系人	贾媛媛	首次公示信息日期	2026-07-24
申请人名称	Bristol-Myers Squibb Company/ 百时美施贵宝（中国）投资有限公司/ Catalent Pharma Solutions, LLC/ Fisher Clinical Services Inc.

登记号	CTR20262871
相关登记号	暂无
药物名称	呫诺美林/曲司氯铵胶囊
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	阿尔茨海默病相关激越
试验专业题目	一项评价 KarXT+KarX-EC 治疗阿尔茨海默病相关激越的长期安全性和耐受性的 III 期、开放标签扩展研究（ADAGIO-3）
试验通俗题目	KarXT+KarX-EC 治疗阿尔茨海默病激越的开放标签扩展研究
试验方案编号	CN012-0025	方案最新版本号	方案修正案01
版本日期:	2025-11-07	方案是否为联合用药	是

申请人名称	[["Bristol-Myers Squibb Company"],["百时美施贵宝（中国）投资有限公司"],["Catalent Pharma Solutions, LLC"],["Fisher Clinical Services Inc."]]
联系人姓名	贾媛媛	联系人座机	010-58237387	联系人手机号	18911913105
联系人Email	yuanyuan.jia@bms.com	联系人邮政地址	北京市-北京市-朝阳区建国门外大街乙12号双子座大厦东塔12F	联系人邮编	100022

在 AD 相关激越 参 与者中 评 估KarXT+KarX-EC 治疗的长期安全性和耐受性

试验分类	安全性	试验分期	III期	设计类型	单臂试验
随机化	非随机化	盲法	开放	试验范围	国际多中心试验

年龄	55岁(最小年龄)至 90岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["参与者须按照方案要求完成研究 CN0120023"],["参与者[或其 LAR， 参见附录 1]须根据监管指南、当地指南和机构指南签署IRB/IEC 批准的书面 ICF，并注明日期。必须在开展任何不属于常规患者诊疗范畴的研究方案相关程序之前获取 ICF。若判定参与者无知情同意能力（由研究者决定），则应根据当地法规的要求，获取参与者的同意。"],["有一名确定的照料者，与参与者保持足够的日常接触（每周约 10 h 或更长时间） 且愿意执行以下事项：n●参加所有访视并报告参与者状态n ●监督参与者的用药和研究程序依从性n●参与研究评估并提供研究参与 IC n● 在非收容机构环境中，照料者与日常陪护者可能是同一人，也可能由不同人担任。在收容机构环境中（例如，疗养院或记忆照护机构），照料者可能是机构工作人员或其他符合上述标准的个体（例如，家属、亲友、雇佣的专业护理人员）。"],["研究者或指定人员应向IOCBP 参与者（定义见方案附录3）以及与IOCBP有性生活活跃的男性（出生时性别）参与者提供关于避孕重要性以及意外妊娠影响的建议。"]]
排除标准	[["既往或当前（包括参与研究 CN0120023 或 CN0120024 期间可能出现的疾病）存在具有临床意义的心血管疾病（例如，未经治疗或不稳定的高血压、具有临床意义的心动过速）、肺病、肾病、血液疾病、GI（例如，阻塞性疾病，包括可能降低GI 动力的疾病，如溃疡性结肠炎、肠无力和重症肌无力）、内分泌疾病、免疫疾病、皮肤病、神经系统疾病或肿瘤，或研究者认为可能危害参与者安全或影响研究结果有效性的任何其他疾病。"],["所有级别的肝功能损害（轻度[Child-Pugh A 级]、中度[Child-Pugh B 级]和重度[Child-Pugh C 级]）。"],["如果研究者和/或申办方/医学监查员判定参与者不适合入组研究，或经研究者和/ 或申办方/医学监查员判断，参与者存在任何可能损害其安全或影响其遵守方案访视计划或满足访视要求的状况，该参与者不得参与研究。"],["经研究者临床评估和/或 C-SSRS 确定的研究期间自杀行为风险，并通过以下方式确认：ni) 对条目 3、4 或 5（C-SSRS 自杀想法）回答为―是‖，且最近一次发作发生在筛选前 2 个月内，或"],["ii) 对 5 个条目中的任一项（C-SSRS 自杀行为）回答为―是‖，且在筛选前 12个月内发作"],["存在以下任何情况的参与者（包括CN0120023或CN0120024研究期间可能发生的情况）：na) 膀胱结石史nb) 复发性尿路感染史nc) 对于男性参与者，IPSS中第1、3、5或6项评分为5分（即，―几乎总是‖）"],["d) 对于男性参与者，IPSS中第1、3、5和6项的评分总和≥9分n6) 筛选时 eGFR≤50 mL/minn7) 筛选时 ALT 或 AST≥2×ULNn8) 胆红素>1.5×ULN，除非合并有 Gilbert 综合征，此情况下总胆红素必须≤3×ULN，且直接胆红素≤ULN。"],["9) 存在不稳定高血压或心动过速的病史，证据包括：ni) 筛选时血压≥160/100 mmHg（基于 3 次坐位测量的平均值）nii) 筛选时心率≥100 bpm（基于 3 次坐位测量的平均值）"],["10)苯环利定、安非他明、阿片类、可卡因或酒精（研究者判定具有临床意义的饮酒）的尿液毒理学筛查结果呈阳性n11) 筛选时，体格检查、病史、ECG（男性 QTcF>450 ms，女性 QTcF>470 ms）或临床实验室检查结果出现具有临床意义的异常n12) 无法遵守第7.7节：既往和合并治疗和附录4中列出的说明和禁用治疗要求。"]]

试验药

[["中文通用名:呫诺美林/曲司氯铵胶囊 英文通用名:BMS-986510KarXTBMS-986510KarXT(Xanomeline/Trospium) 商品名称:Cobenfy™（呫诺美林-曲司氯铵[GQ1]）[MM2][GQ3]","剂型:口服胶囊 规格:14mg/3mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:呫诺美林/曲司氯铵胶囊 英文通用名:：BMS-986510KarXTBMS-986510KarXT(Xanomeline/Trospium) 商品名称:Cobenfy™（呫诺美林-曲司氯铵[GQ1]）[MM2][GQ3]","剂型:口服胶囊 规格:28mg/6mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:呫诺美林/曲司氯铵胶囊 英文通用名:BMS-986510KarXTBMS-986510KarXT(Xanomeline/Trospium) 商品名称:Cobenfy™（呫诺美林-曲司氯铵[GQ1]）[MM2][GQ3]","剂型:口服胶囊 规格:42mg/9mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:呫诺美林/曲司氯铵胶囊 英文通用名:BMS-986510KarXTBMS-986510KarXT(Xanomeline/Trospium) 商品名称:Cobenfy™（呫诺美林-曲司氯铵[GQ1]）[MM2][GQ3]","剂型:口服胶囊 规格:56mg/12mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:BMS-986519KarX-EC(呫诺美林肠溶胶囊) 英文通用名:BMS-986519KarX-EC(Xanomeline) 商品名称:NA","剂型:口服胶囊 规格:14mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:BMS-986519KarX-EC(呫诺美林肠溶胶囊) 英文通用名:BMS-986519KarX-EC(Xanomeline) 商品名称:NA","剂型:口服胶囊 规格:28mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:BMS-986519KarX-EC(呫诺美林肠溶胶囊) 英文通用名:BMS-986519KarX-EC(Xanomeline) 商品名称:NA","剂型:口服胶囊 规格:42mg 用法用量:口服/一日两次 用药时程:治疗周期26周"],["中文通用名:BMS-986519KarX-EC(呫诺美林肠溶胶囊) 英文通用名:BMS-986519KarX-EC(Xanomeline) 商品名称:NA","剂型:口服胶囊 规格:56mg 用法用量:口服/一日两次 用药时程:治疗周期26周"]] 序号 名称 用法

对照药

暂未填写此信息 序号 名称 用法

主要终点指标及评价时间	[["TEAE 发生率","在 AD 相关激越 参 与者中 评 估KarXT+KarX-EC 治疗的长期安全性和耐受性","安全性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["报告的 AE、SAE、导致退出研究的TEAE 以及死亡；AESI；BARS 和 AIMS；体重和 BMI；直立性生命体征：血压（收缩压和舒张压）和心率；临床实验室评估","在 AD 相关激越 参 与者中 评 估","安全性指标"],["12 导联 ECG；通过 C-SSRS 评估自杀想法；通过 MMSE 和 ADAS-Cog-13 评估认知功能；通过 IPSS 评估男性参与者良性前列腺增生的严重程度","KarXT+KarX-EC 治疗的长期安全性和耐受性","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	唐毅	学位	医学博士	职称	正高级/主任医师
	电话	13811021432	Email	tangyi@xwhosp.org	邮政地址	北京市-北京市-西城区长椿街45号
	邮编	100053	单位名称	首都医科大学宣武医院（北京市老年保健及疾病防治中心、北京功能神经外科研究所）

[["首都医科大学宣武医院（北京市老年保健及疾病防治中心、北京功能神经外科研究所）","唐毅","中国","北京市","北京市"],["南京大学鼓楼医院","徐运","中国","江苏省","南京市"],["广州医科大学第二附属医院","刘军","中国","广东省","广州市"],["中南大学湘雅医院","沈璐","中国","湖南省","长沙市"],["浙江大学医学院附属第一医院","魏宁","中国","浙江省","杭州市"],["广州医科大学附属脑科医院","宁玉萍","中国","广东省","广州市"],["北京安定医院","张庆娥","中国","北京市","北京市"],["昆明医科大学附属第一医院","卢瑾","中国","云南省","昆明市"],["重庆医科大学附属第一医院","吕洋","中国","重庆市","重庆市"],["天津安定医院","李洁","中国","天津市","天津市"],["北京大学第六医院","王华丽","中国","北京市","北京市"],["西安市精神卫生中心","党伟","中国","陕西省","西安市"],["浙江大学医学院附属邵逸夫医院","陈炜","中国","浙江省","杭州市"],["深圳康宁医院","王永军","中国","广东省","深圳市"],["四川华西医院","况伟宏","中国","四川省","成都市"],["上海市同济医院","汪锡金","中国","北京市","北京市"],["Centro Medico Luquez","Juan Luquez","阿根廷","Cordoba","Cordoba"],["INSA Instituto de Neurociencia San Agustin","Hector Fabian Lamaison","阿根廷","Buenos Aires","La Plata"],["Hospital Privado de Comunidad","Maria Emilia Clement","阿根廷","Buenos Aires","Mar del Plata"],["Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI)","Ricardo Allegri","阿根廷","Buenos Aires","Buenos Aires"],["CEN Centro Especializado en Neurociencias","Hernan Ruggeri","阿根廷","Cordoba","Cordoba"],["Instituto Privado Kremer","Leonardo Kremer","阿根廷","Cordoba","Cordoba"],["Fundacion Estudios Clinicos","Javier Travella","阿根廷","Santa Fe","Rosario"],["Ruschel Medicina e Pesquisa Clinica","Sandra Ruschel","巴西","Rio de Janeiro","Rio de Janeiro"],["L2IP - Instituto de Pesquisas Clinicas","Eduardo Vasconcellos","巴西","Distrito Federal","Brasilia"],["PUCTrials","Carlos Twardowschy","巴西","Parana","Curitiba"],["CECPAR - Centro de Estudos Clinicos do Parana","Luiz Petry","巴西","Parana","Curitiba"],["Hospital Moinhos de Vento","Wyllians Borelli","巴西","Rio Grande do Sul","Porto Alegre"],["CPQuali Pesquisa Clinica","Leonel Takada","巴西","Sao Paulo","Sao Paulo"],["Clinica Viver - Centro de Desospitalizacao Humana","Claudiane Daltion","巴西","SP","Sao Paulo"],["Instituto de Pesquisa Clinica de Campinas","Alexandre Pieri","巴西","SP","Campinas"],["Nucleo de Pesquisa Clinica do Rio Grande do Sul","Clarissa Gama","巴西","Rio Grande do Sul","Porto Alegre"],["Medical Center Sveti Naum EOOD","Assen Karadaliev","保加利亚","Sofia-Grad","Sofia"],["Medical Center Medconsult Pleven OOD","Mariya Alexandrova-Stoycheva","保加利亚","Pleven","Pleven"],["Medical Center Mladost","Hristo Kozhuharov","保加利亚","Varna Province","Varna"],["Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova","Madlena Borisova","保加利亚","Razgrad Province","Razgrad"],["Sunnybrook Research Institute","Sandra Black","加拿大","ON","Toronto"],["Ontario Shores Centre For Mental Health Sciences","Amer Burhan","加拿大","ON","Whitby"],["GERAS Centre for Aging Research","Alexandra Papaioannou","加拿大","ON","Hamilton"],["Centre for Addiction & Mental Health","Sanjeev Kumar","加拿大","ON","Toronto"],["London Health Sciences Centre-Victoria Campus","Tuoyo Awani","加拿大","ON","London"],["Klinicki bolnicki centar Zagreb","Natasa Klepac","克罗地亚","Grad Zagreb","Zagreb"],["Clinical Hospital Center Split","Trpimir Glavina","克罗地亚","NA","Split"],["General Hospital Varazdin","Spomenka Kidemet-Piskac","克罗地亚","NA","Varazdin"],["Poliklinika Bonifarm-Hondlova 2/11","Tanja Potocki Karacic","克罗地亚","Grad Zagreb","Zagreb"],["Klinicki Bolnicki Centar Rijeka","Vladimir Sabljic","克罗地亚","NA","Rijeka"],["Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala","Mihaela Rosca","罗马尼亚","NA","Bucuresti"],["Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila","Octavian Vasiliu","罗马尼亚","NA","Bucuresti"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","ADELA CIOBANU","罗马尼亚","Bucuresti","Bucuresti"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","Valentin Matei","罗马尼亚","Bucuresti","Bucuresti"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","Mihnea Manea","罗马尼亚","Bucuresti","Bucuresti"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","SIMONA TRIFU","罗马尼亚","Bucuresti","Bucuresti"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","Corina Nicolae","罗马尼亚","Bucuresti","Bucuresti"],["Institutul de Psihiatrie Socola","CRISTINEL STEFANESCU","罗马尼亚","Iasi","Iasi"],["Prof. Dr. Alexandru Obregia Psychiatry Hospital","Laura Cristina Dolis","罗马尼亚","Bucuresti","Bucuresti"],["Centrul de Evaluare si Tratament a Toxicodependentei pentru Tineri Sf.Stelian","Traian Barbu","罗马尼亚","NA","Bucharest"],["Spitalul de Psihiatrie si Neurologie Brasov","Petru Iulian Ifteni","罗马尼亚","NA","Sanpetru /Brasov"],["Cai Ferate Clinical Hospital Constanta","Ana Maria Ionescu","罗马尼亚","NA","Constanta"],["Clinical Psychiatric Hospital Dr. Gheorghe Preda","Ciprian Bacila","罗马尼亚","NA","Sibiu"],["Monroe Biomedical Research","Awawu Igbinadolor","美国","North Carolina","Monroe"],["Premier Clinical Research Institute","Emelina Arocha","美国","Florida","Miami"],["Nuovida Research Center","Jorge Betancourt, MD","美国","Florida","Miami"],["Hope Research Network - Miami","Jorge Jorge","美国","Florida","Miami"],["Progressive Medical Research","Alexander White","美国","Florida","Port Orange"],["Imaging Endpoints","Nida Laurin","美国","Arizona","Scottsdale"],["Oakland Medical Research","Jay Sandberg","美国","Michigan","Troy"],["Combined Research Orlando (CRO)","Eric Carbonell","美国","Florida","Orlando"],["CBH Health","Elia Acevedo Diaz","美国","Maryland","Gaithersburg"],["Kaizen Brain Center","Janne Nissinen","美国","California","La Jolla"],["Boston Center for Memory","Paul Solomon","美国","Massachusetts","Newton"],["Torrance Clinical Research","Marina Raikhel","美国","California","Torrance"],["Central States Research","Sarah Land","美国","Oklahoma","Tulsa"],["Wasatch Clinical Research, LLC","Albert Jarvi","美国","Utah","Salt Lake City"],["Mayflower Clinical Research","Simon Desjardins","美国","Massachusetts","Dartmouth"],["Advanced Neurology Epilepsy and Sleep Center","Aamr Herekar","美国","Texas","El Paso"],["The Memory Clinic","Lisa Catapano-Friedman","美国","Vermont","Bennington"],["Patient First MD","Matthew Davis","美国","New Jersey","Middletown"],["Redbird Research","Jelena Kunovac","美国","Nevada","Las Vegas"],["Sunwise Clinical Research","Ira Glick","美国","California","Walnut Creek"],["Midlands Neurology and Pain Associates","Eleanya Ogburu-Ogbonnaya","美国","South Carolina","Columbia"],["Kingfisher Cooperative","David Greeley","美国","Washington","Spokane"],["Mid Hudson Medical Research","Sashi Makam","美国","New York","New Windsor"],["Advanced Research Center (ARC) - Anaheim","Steven Macina","美国","California","Anaheim"],["Five Towns Neurology PC -Woodmere - 923 Broadway","David Steiner","美国","New York","Woodmere"],["Dayton Center for Neurological Disorders","Megan Mackenzie","美国","Ohio","Centerville"],["Elixia MA","Brittany Perreault","美国","Massachusetts","Springfield"],["Velocity Clinical Research, Savannah","Paul Bradley","美国","Georgia","Savannah"],["The Neurology Group","Sadiq Altamimi","美国","California","Pomona"],["Global Medical Institutes LLC; Princeton Medical Institute","Sanjay Varma","美国","New Jersey","Princeton"],["NeuroBehavioral Medicine Group","Richard Jackson","美国","Michigan","Bloomfield Hills"],["Clinical Research Institute S.C.","DANIEL ORTA","墨西哥","Mexico","Tlalnepantla de Baz"],["Hospital Universitario de Saltillo","MARIO VALDES","墨西哥","Coahuila","Saltillo"],["Boca Clinical Trials Mexico S.C.","Hector Cruz Neri","墨西哥","Jalisco","Guadajalara"],["Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez","Ramiro Ruiz Garcia","墨西哥","MEXICO","Mexico City"],["Neurociencias PRISMA A.C.","Carlos Guerra Galicia","墨西哥","San Luis Potosi","San Luis Potosi"],["Innovacion y Desarrollo en Ciencias de la Salud","Virgilio Hernandez Ruiz","墨西哥","Mexico City","Mexico City"],["AVIX Investigacion Clinica","Amador Macias","墨西哥","NA","Monterrey"],["Campus Neurologico Senior","Camila Nobrega","葡萄牙","NA","Torres Vedras"],["Unidade Local de Saude de Coimbra, E.P.E.","Isabel Santana","葡萄牙","NA","Coimbra"],["Centro Hospitalar do Alto Ave","Joana Meireles","葡萄牙","NA","Guimaraes"],["Unidade Local de Saude de Matosinhos SA","Vitor Tedim Cruz","葡萄牙","NA","Senhora da Hora"],["Centro Hospitalar Universitario Lisboa Norte, E.P.E. – Hospital de Santa Maria","Ana Verdelho","葡萄牙","NA","Lisboa"],["Rainbow and Sea Hospital","Taro Shindo","日本","Saga-Ken","Karatsu-shi"],["Hatano Kousei Hospital","Sakai Yoshiro","日本","KANAGAWA","Hadano"],["Kuramitsu Hospital","Noriko Tamaru","日本","NA","Fukuoka"],["National Hospital Organization Hizen Psychiatric Center","Manabu Hashimoto","日本","Saga","Kanzaki-Gun Yoshinogari-Cho"],["Asakayama General Hospital","Kazue Kamae","日本","OSAKA","Sakai"],["Nippon Medical School Hospital","Amane Tateno","日本","TOKYO","Bunkyo-ku"],["Okayama City General Medical Center Okayama City Hospital","Kentaro Deguchi","日本","Okayama","Okayama"],["Teikyo University Mizonokuchi Hospital","Makoto Nakane","日本","Kanagawa","Kawasaki"],["Jichi Medical University Hospital","Shiro Suda","日本","NA","Shimotsuke-shi, Tochigi"],["Taipei Veterans General Hospital","Jong-Ling Fuh","中国台湾","NA","Taipei"],["National Cheng Kung University Hospital","Ming-Chyi Pai","中国台湾","NA","Tainan, Taiana"],["Chang Gung Medical Foundation-Linkou Branch","Yi-chun Chen","中国台湾","NA","Taoyuan"],["Chang Gung Memorial Hospital at Kaohsiung","Chiung-Chih Chang","中国台湾","Kaohsiung","Kaohsiung Niao Sung Dist"],["National Taiwan University Hospital","Yi-Ting Lin","中国台湾","NA","Taipei"],["Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca","Angel Luis Montejo","西班牙","NA","Salamanca"],["Hospital Viamed Montecanal","Antonio Oliveros-Cid","西班牙","Zaragoza","Zaragoza"],["Hospital Clinico Universitario Virgen de La Victoria","Carlos De La Cruz Cosme","西班牙","Malaga","Malaga"],["Hospital Victoria Eugenia de Sevilla","Felix Vinuela Fernandez","西班牙","NA","Sevilla"],["Hospital Mutua Terrassa","Jerzy Krupinski","西班牙","NA","Terrassa"],["Hospital Clinico San Carlos","Jordi Matias Guiu","西班牙","Madrid","Madrid"],["Hospital Universitario De Rio Hortega","Juan Munoz Sanchez","西班牙","NA","Valladolid"],["Clinica Universidad de Navarra","Mario Riverol Fernandez","西班牙","NA","Pamplona"],["Complejo Hospitalario Ruber Juan Bravo","Juan Lopez Lozano","西班牙","NA","Madrid"],["Hospital General Universitario de Elche","Maria Gloria Gonzalez Caballero","西班牙","NA","Elche (alicante)"],["Oroitu Centro de Atencion Especializada","Manuel Fernandez","西班牙","Bizkaia","Getxo"],["UNIVERSITY HOSPITAL OF PATRAS","John Ellul","希腊","Achaia","PATRAS"],["University Hospital of Ioannina","Spyridon KONITSIOTIS","希腊","NA","Ioannina"],["Eginition Hospital","NIKOS STEFANIS","希腊","NA","Athens"],["University General Hospital ATTIKON - General Hospital of West Attica H AGIA VARVARA","Georgios Tsivgoulis","希腊","Attiki","Chaidari"],["Euromedica General Clinic of Thessaloniki","Magda Tsolaki","希腊","NA","Thessaloniki"],["Henry Dunant Hospital Center","Konstantina Yiannopoulou","希腊","Attiki","Athens"],["Aiginiteio University Hospital","Nikolaos Scarmeas","希腊","Attiki","Athens"],["Athens Medical Center","John Papatriantafyllou","希腊","NA","Athens"],["Apollo Multispeciality Hospitals limited","AMITABHA GHOSH","印度","West Bengal","Kolkata"],["Asha Hospital","G Rao","印度","Andhra Pradesh","Hyderabad"],["Yashoda Hospitals","Jaydip Chaudhuri","印度","Telangana","Hyderabad"],["All India Institute Of Medical Sciences","Patil Vaibhav","印度","NA","New Delhi"],["Deva Institute Of Healtcare & Research Pvt. Ltd.","Venu Jhanwar","印度","Uttar Pradesh","Varanasi"],["GMERS Medical College Sola Ahmedabad","Pradhyuman Chaudhary","印度","Gujarat","Ahmedabad"],["Institute Of Human Behaviour And Allied Sciences","Suman Kushwaha","印度","NA","Delhi"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["首都医科大学宣武医院伦理委员会","同意","2026-05-27"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 39 ； 国际: 320 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；