[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583537":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":41,"studyPopulation":11,"armGroups":42,"interventions":52,"overallOfficials":11,"centralContacts":63,"locations":69,"responsibleParty":88,"collaborators":90,"id":93,"slug":11,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Seismic Therapeutic AU Pty Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0",null,"2 months",[14,16,18,20,22,24,26,28,30],{"measure":15,"description":11,"timeFrame":12},"To assess the maximum serum concentration (CMAX)",{"measure":17,"description":11,"timeFrame":12},"To assess time to reach maximum serum concentration (tMAX)",{"measure":19,"description":11,"timeFrame":12},"To assess elimination half-life (t1\u002F2)",{"measure":21,"description":11,"timeFrame":12},"To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)",{"measure":23,"description":11,"timeFrame":12},"To assess clearance (CL)",{"measure":25,"description":11,"timeFrame":12},"To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)",{"measure":27,"description":11,"timeFrame":12},"To assess bioavailability after SC administration (F%)",{"measure":29,"description":11,"timeFrame":12},"To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints",{"measure":31,"description":11,"timeFrame":12},"Incidence and characterization of anti-drug antibody (ADA)",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":11,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","INVESTIGATOR","This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).",[43,49],{"label":44,"type":45,"description":11,"interventionNames":46},"S-4321 Part 1: Single ascending dose (SAD) cohorts","EXPERIMENTAL",[47,48],"Drug: S-4321","Other: Placebo",{"label":50,"type":45,"description":11,"interventionNames":51},"S-4321 Part 2: Multiple ascending dose (MAD) cohorts",[47,48],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"DRUG","S-4321","S-4321 via subcutaneous or intravenous administration",[44,50],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"OTHER","Placebo","Placebo via subcutaneous or intravenous administration.",[44,50],[64],{"name":65,"role":66,"phone":67,"phoneExt":11,"email":68},"Seismic Contact","CONTACT","1800 244 475","clinical@seismictx.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":11,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Veritus Research","RECRUITING","Bayswater","Victoria","Australia","AU",{"type":78,"coordinates":79},"Point",[80,81],145.26667,-37.85,{"lat":81,"lon":80},[84],{"name":85,"role":66,"phone":86,"phoneExt":11,"email":87},"Veritus Contact","+61 3 8736 1750","info@veritusresearch.com",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[91],{"name":92,"class":6},"Avance Clinical Pty Ltd.","100583537",false,"NCT06877611","A Phase 1 Study of S-4321","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers","Inclusion Criteria:\n\n1. Is available for the entire duration of the study and follow up.\n2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).\n4. Has a body mass index (BMI) within 18 to 32 kg\u002Fm2, inclusive, and weighs ≥45 kg.\n5. Is in good physical and mental health in the opinion of the Investigator or delegate.\n\nMajor Exclusion Criteria:\n\n1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.\n2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.\n3. Has a known immunodeficiency disorder.\n4. Has a history of malignancy or confirmed cervical dysplasia.\n5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.\n6. Has positive laboratory evidence for active hepatitis at screening.\n7. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.\n\nOther inclusion\u002Fexclusion eligibility criteria apply.",true,"ALL","18 Years","65 Years",{"count":104,"type":105},96,"ESTIMATED","INTERVENTIONAL",[108],"PHASE1","This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.",[111],"Healthy Volunteer","2025-04-10",{"date":114,"type":115},"2025-04-15","ACTUAL",{"date":117,"type":115},"2025-04-03",{"date":119,"type":105},"2026-04",{"name":5,"class":6},1]