[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626717":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":48,"studyPopulation":35,"armGroups":49,"interventions":62,"overallOfficials":35,"centralContacts":71,"locations":80,"responsibleParty":95,"collaborators":35,"id":97,"slug":35,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":35,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":35,"maxAge":105,"enrollmentInfo":106,"targetDuration":35,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":35,"overallStatus":83,"whyStopped":35,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Hinge Bio","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety and Tolerability","Incidence\u002Fseverity of AEs and SAEs (CTCAE v5.0)","Time Frame: Day 1 to Day 28; may extend to Month 2",{"measure":14,"description":15,"timeFrame":16},"Dose Limiting Toxicities (DLTs)","DLT's as defined within the protocol.","Day 1 through Day 28",[18,22,24,26,29,32],{"measure":19,"description":20,"timeFrame":21},"To characterize the pharmacokinetic (PK) profile of HB2198","Area under the concentration versus time curve (AUC)","Day 1 to Month 2",{"measure":19,"description":23,"timeFrame":21},"Maximum drug concentration (Cmax)",{"measure":19,"description":25,"timeFrame":21},"Time to maximum plasma concentration (tmax)",{"measure":27,"description":28,"timeFrame":21},"To characterize the pharmacokinetic (PK) profile of HB2198:","Area Under the Curve to last measurable concentration (AUClast)",{"measure":30,"description":31,"timeFrame":21},"To evaluate the development of anti-drug antibodies (ADAs)","ADA incidence",{"measure":33,"description":34,"timeFrame":21},"To evaluate B-cell depletion and other pharmacodynamic changes","B-cell depletion and subsets; duration; change in total immunoglobulins; cytokines\u002FCRP and other biomarkers.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","HB2198 and HB2198 Diluent (Placebo)","TREATMENT",{"masking":42,"maskingDescription":35,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","HB2198 is a tetravalent bispecific antiCD19\u002FCD20 antibody engineered with dual Fc domains (S239D\u002FI332E) to enhance FcγR engagement. Cohorts (n=8 each) receive a single IV dose of HB2198 or placebo under double blind conditions; 2 sentinels (1 active, 1 placebo) are dosed ≥48 h before the remaining 6 participants. Safety\u002FPK\u002FPD and immunogenicity are characterized through Day 28 and to Month 2, including B-cell depletion kinetics, lymphocyte phenotyping, cytokines, quantitative immunoglobulins, and ADAs.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains","ACTIVE_COMPARATOR","HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1. There are 4 planned dose levels: 0.001 mg\u002Fkg → 0.1 mg\u002Fkg.",[55],"Drug: Placebo comparator: HB2198 Diluent",{"label":57,"type":58,"description":59,"interventionNames":60},"HB2198 Diluent (IV)","PLACEBO_COMPARATOR","HB2198 Diluent administered via IV infusion on Day 1",[61],"Drug: HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":35},"DRUG","Drug: HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.",[57],{"type":64,"name":68,"description":69,"armGroupLabels":70,"otherNames":35},"Placebo comparator: HB2198 Diluent","HB2198 Diluent: single IV infusion",[51],[72,77],{"name":73,"role":74,"phone":75,"phoneExt":35,"email":76},"Joshua Pelham","CONTACT","1-415-378-4738","joshua.pelham@hingebio.com",{"name":78,"role":74,"phone":35,"phoneExt":35,"email":79},"Kristen Quigley","kristen.quigley@hingebio.com",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":35},"Veritus Research","RECRUITING","Bayswater","Victoria","3153","Australia","AU",{"type":90,"coordinates":91},"Point",[92,93],145.26667,-37.85,{"lat":93,"lon":92},{"type":96,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100626717",false,"NCT07439263","Single Ascending Dose Study of HB2198 in Healthy Participants","A Phase 1, Randomized, Double Blinded, Placebo Controlled Dose Escalating Single Ascending Dose Study of HB2198, a Tetravalent Bispecific Anti CD19\u002FCD20 Antibody With Dual Fc Domains, in Healthy Participants","Inclusion Criteria:\n\n* 18-55 years; Healthy Adults\n* IgG ≥ 600 mg\u002FdL\n* Peripheral B cell count within lab normal range\n* Negative pregnancy test (WOCBP) and protocol specified contraception\n* Confinement from Day -1 through ≥24 h after Day 1 dosing\n* Informed consent\n\nExclusion Criteria:\n\n* Clinically significant disease that could affect safety or data\n* Hypogammaglobulinemia; active\u002Frecent significant infection\n* Chronic antivirals\u002Fantimicrobials\n* Recent major surgery; live vaccine \\\u003C30 days (inactivated ≥14 days before Day 1 recommended)\n* Positive TB screen without treatment\n* HBV DNA+ or HCV RNA+; HIV+\n* Pregnancy\u002Fbreastfeeding\n* Planned conception or gamete donation within 6 months post dose",true,"ALL","55 Years",{"count":107,"type":108},32,"ESTIMATED","INTERVENTIONAL",[111],"PHASE1","Phase 1, single center, randomized, double blind, placebo controlled SAD study assessing safety, tolerability, PK, PD, and immunogenicity of HB2198 after a single IV infusion in healthy adults. Four dose levels will be explored with sentinel participants per cohort. Approximately 32 participants (6 HB2198:2 placebo per cohort) will be followed for \\~2 months, with extended follow up if B-cell counts remain suppressed.",[114],"Healthy Volunteer","2026-04-07",{"date":117,"type":118},"2026-04-13","ACTUAL",{"date":120,"type":118},"2026-03-19",{"date":122,"type":108},"2026-08-21",{"name":5,"class":6},1]