[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperlipoproteinemia-a\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperlipoproteinemia-a":29},{"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":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100606214","phase-1-a-study-of-srsd216-in-patients-with-elevated-lipoprotein-a-100606214",false,"NCT07172646","A Study of SRSD216 in Patients With Elevated Lipoprotein (a)","A Phase I\u002FII, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)","Inclusion Criteria:\n\n* Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;\n* Males or females, of any race;\n* Body mass index (BMI) between 18.0 and 40.0 kg\u002Fm2, inclusive;\n* Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.\n\nExclusion Criteria:\n\n* Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;\n* Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);\n* Acute febrile illness within 7 days prior to dose administration or evidence of active infection;\n* Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;\n* History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;\n* Fasting TG≥ 500 mg\u002FdL (5.6 mmol\u002FL) during screening;\n* Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;\n* Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.",true,"ALL","18 Years","70 Years",{"count":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.",[29],"Hyperlipoproteinemia (a)","RECRUITING","2026-01-03",{"date":33,"type":34},"2026-01-06","ACTUAL",{"date":36,"type":34},"2025-04-07",{"date":38,"type":22},"2027-04",{"name":40,"class":41},"Sirius Therapeutics Co., Ltd.","INDUSTRY"]