[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-inflammatory-bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-inflammatory-bowel-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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 Inflammatory Bowel Disease","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection or Intravenous Infusion of SHR-7590 Injection in Healthy Chinese Participants and Participants With Moderate-to-Severe Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)","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":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"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 inflammatory bowel disease.",[28],"Moderate-to-severe Inflammatory Bowel Disease","RECRUITING","2026-09-22",{"date":32,"type":33},"2026-09-25","ACTUAL",{"date":35,"type":33},"2026-08-21",{"date":37,"type":22},"2027-12",{"name":39,"class":40},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY"]