[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626717":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":25,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hinge Bio","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Placebo comparator: HB2198 Diluent",{"label":15,"type":16,"description":17,"interventionNames":18},"HB2198 Diluent (IV)","PLACEBO_COMPARATOR","HB2198 Diluent administered via IV infusion on Day 1",[19],"Drug: HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Drug: HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody with Dual Fc Domains administered via IV infusion on Day 1.",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo comparator: HB2198 Diluent","HB2198 Diluent: single IV infusion",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Joshua Pelham","CONTACT","1-415-378-4738","joshua.pelham@hingebio.com",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Kristen Quigley","kristen.quigley@hingebio.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Veritus Research","RECRUITING","Bayswater","Victoria","3153","Australia","AU",{"type":49,"coordinates":50},"Point",[51,52],145.26667,-37.85,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100626717","phase-1-single-ascending-dose-study-of-hb2198-in-healthy-participants-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":67,"type":68},32,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Healthy Volunteer","2026-04-07",{"date":77,"type":78},"2026-04-13","ACTUAL",{"date":80,"type":78},"2026-03-19",{"date":82,"type":68},"2026-08-21",{"name":5,"class":6},1]