[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651166":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":36,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":36,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":36,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":36,"overallStatus":86,"whyStopped":36,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level：A","EXPERIMENTAL","Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A.",[13,14],"Drug: SHR-7590","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose Level：B","Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Level：C","Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Level：D","Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Dose Level：E","Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E.",[13,14],[32,37],{"type":33,"name":34,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","SHR-7590",[9,16,20,24,28],null,{"type":33,"name":38,"description":38,"armGroupLabels":39,"otherNames":36},"Placebo",[9,16,20,24,28],[41],{"name":42,"role":43,"phone":44,"phoneExt":36,"email":45},"Si Chen","CONTACT","0518-82342973","si.chen@hengrui.com",[47],{"facility":48,"status":36,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009","China","CN",{"type":55,"coordinates":56},"Point",[57,58],120.16142,30.29365,{"lat":58,"lon":57},[61],{"name":62,"role":63,"phone":36,"phoneExt":36,"email":36},"Bo Jiang","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100651166","phase-1-a-study-to-evaluate-the-safety-of-shr-7590-in-chinese-healthy-participants-and-in-patients-with-moderate-to-severe-ulcerative-colitis-100651166",false,"NCT07758101","A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-Severe Ulcerative Colitis","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-7590 Via Subcutaneous or Intravenous Administration in Chinese Healthy Participants and Patients With Moderate-to-Severe Ulcerative Colitis","Inclusion Criteria:\n\n\\- Part 1\n\n* Voluntarily signed the informed consent form\n* Age from 18 to 55 years old\n* Body weight ≥45 kg, body mass index (BMI) 18-26 kg\u002Fm2\n* Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations\n* Adopt efficient contraceptive measures\n\nExclusion Criteria:\n\n\\- Part 1\n\n* Suspected allergy to the study drug or any component of the study drug\n* Any clinical disease or any other disease that could interfere with the test results\n* Had a history of malignant tumor\n* Had an opportunistic infection within 6 months before screening\n* Acute infection with constitutional symptoms within 4 weeks before baseline\n* Participants who participated in any drug or device clinical trial within 3 months before screening\n* Use of any drug within 1 month before the use of the investigational drug\n* Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening\n* Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial\n* History of blood donation within 1 month before screening, or severe blood loss",true,"ALL","18 Years","55 Years",{"count":78,"type":79},64,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe ulcerative colitis.",[85],"Moderate to Severe Ulcerative Colitis","NOT_YET_RECRUITING","2026-08-05",{"date":89,"type":90},"2026-08-11","ACTUAL",{"date":92,"type":79},"2026-08",{"date":94,"type":79},"2027-12",{"name":5,"class":6},1]