[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610758":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Stelexis BioSciences","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"STLX-2012","EXPERIMENTAL","Single ascending doses of STLX-2012",[13],"Drug: STLX-2012",{"label":15,"type":16,"description":15,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","STLX-2012 IV",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":24},"OTHER","Placebo arm",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Clinical Trials Office","CONTACT","508-543-6979","clinicaltrials@stelexis.com",[36],{"facility":37,"status":24,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Nucleus Network Brisbane","Brisbane","Queensland","4006","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],153.02809,-27.46794,{"lat":47,"lon":46},[50],{"name":37,"role":32,"phone":51,"phoneExt":24,"email":52},"1800 243 733","brisbane@nucleusnetwork.com",{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100610758","phase-1-study-of-stlx-2012-in-healthy-volunteers-100610758",false,"NCT07231744","Study of STLX-2012 in Healthy Volunteers","A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of STLX-2012 in Healthy Volunteers","Inclusion Criteria:\n\n* Male or female participants aged 18-55 years old, inclusive, at Screening.\n* Body mass index of 18-32 kg\u002Fm\\^2, inclusive\n* Healthy as determined by the investigator\n* Adequate hepatic and renal function\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Male participants and females of childbearing potential must agree to use an effective method of contraception for 30 days after the last dose of STLX-2012\n\nExclusion Criteria:\n\n* Pregnant or lactating female.\n* Positive urine drug screen or alcohol breath test\n* Neutropenia, defined as neutrophil count \\\u003C2.0 x 10\\^9\u002FL\n* History of allergic reaction requiring treatment or anaphylactic reactions to any therapeutic drug.\n* Previous treatment with an IL-1RAP monoclonal antibody\n* History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (excluding mild seasonal allergies)",true,"ALL","18 Years","55 Years",{"count":67,"type":68},32,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.",[74],"Healthy Participants","NOT_YET_RECRUITING","2026-04-21",{"date":78,"type":79},"2026-04-22","ACTUAL",{"date":81,"type":68},"2026-10",{"date":83,"type":68},"2027-02",{"name":5,"class":6},1]