[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606214":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":67,"collaborators":34,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":34,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":34,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":34,"overallStatus":52,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Sirius Therapeutics Co., Ltd.","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"SRSD216 injection (Part 1)","EXPERIMENTAL","SRSD216 administered SC. in subjects of Part 1",[13],"Drug: SRSD216 injection",{"label":15,"type":10,"description":16,"interventionNames":17},"SRSD216 injection (Part 2)","SRSD216 administered SC. in subjects of Part 2",[13,18],"Drug: Placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"0.9% Sodium Chloride (Part 1)","Placbo administered SC. in subjects of Part 1",[18],{"label":24,"type":25,"description":26,"interventionNames":27},"0.9% Sodium Chloride (Part 2)","PLACEBO_COMPARATOR","Placbo administered SC. in subjects of Part 2",[13,18],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","SRSD216 injection","Administered SC.",[24,9,15],null,{"type":30,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Placebo",[20,24,15],[39],{"name":40,"affiliation":41,"role":42},"Medical Director, MD","Sirius Therapeutics","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Medical Director","CONTACT","+86 21 61207756","medical@siriusrna.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Site 01","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":47,"phoneExt":34,"email":48},"Investigator",{"type":68,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","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":81,"type":82},84,"ESTIMATED","INTERVENTIONAL",[85,86],"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.",[89],"Hyperlipoproteinemia (a)","2026-01-03",{"date":92,"type":93},"2026-01-06","ACTUAL",{"date":95,"type":93},"2025-04-07",{"date":97,"type":82},"2027-04",{"name":5,"class":6},1]