[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638083":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":118,"collaborators":25,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":25,"enrollmentInfo":130,"targetDuration":25,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":99,"whyStopped":25,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Diagonal Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DIAG723","EXPERIMENTAL","Participants receive DIAG723 administered subcutaneously.\n\nPart A (dose-escalation): Single ascending dose across planned cohorts, randomized 3:1 DIAG723:placebo.\n\nPart B (multi-dose HHT): Multiple-dose regimens over 13 weeks (7 doses administered every other week), randomized 2:1.\n\nPart C (multi-dose HHT + PAH): Same 13-week multi-dose regimen in patients with pulmonary arterial hypertension, randomized 4:1.\n\nDoses\u002Fregimens in Parts B and C are selected based on Part A safety and PK data.",[13],"Biological: DIAG723",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator","PLACEBO_COMPARATOR","Participants receive placebo (sterile normal saline, 0.9% NaCl) administered subcutaneously in a volume matched to DIAG723 to maintain blinding.\n\nMatching single-dose administration in Part A. Matching multi-dose regimens (every-other-week dosing for 13 weeks) in Parts B and C.\n\nRandomization ratios consistent with each study part (3:1, 2:1, 4:1).",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Bispecific agonist monoclonal antibody targeting ALK-1 and BMPRII, administered subcutaneously as:\n\nSingle ascending dose in Part A; Multiple doses (7 doses over 13 weeks) in Parts B and C",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Placebo","Sterile normal saline (0.9% NaCl) administered subcutaneously in volumes matched to DIAG723 to maintain study blinding.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Diagonal Therapeutics","CONTACT","339-233-4291","clinicalinfo@diagonaltx.com",[38,59,72,88,97],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Royal Prince Alfred Hospital","NOT_YET_RECRUITING","Camperdown","New South Wales","2050","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],151.17642,-33.88965,{"lat":50,"lon":49},[53,56],{"name":25,"role":34,"phone":54,"phoneExt":25,"email":55},"+61 (02) 9382 5800","contactus@scientiaclinicalresearch.com.au",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Edmund Lau, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":40,"city":61,"state":42,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Scientia Clinical Research Ltd","Randwick","2031",{"type":47,"coordinates":64},[65,66],151.24895,-33.91439,{"lat":66,"lon":65},[69,70],{"name":25,"role":34,"phone":54,"phoneExt":25,"email":55},{"name":71,"role":58,"phone":25,"phoneExt":25,"email":25},"Christopher Argent, MD",{"facility":73,"status":40,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Doherty Clinical Trials","East Melbourne","Victoria","3002",{"type":47,"coordinates":78},[79,80],144.9879,-37.81667,{"lat":80,"lon":79},[83,86],{"name":25,"role":34,"phone":84,"phoneExt":25,"email":85},"(03) 9970 4200","info@dohertyclinicaltrials.com",{"name":87,"role":58,"phone":25,"phoneExt":25,"email":25},"James McCarthy, MD",{"facility":89,"status":40,"city":90,"state":75,"zip":91,"country":44,"countryCode":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":25},"Royal Melbourne Hospital","Parkville","3050",{"type":47,"coordinates":93},[94,95],144.95,-37.78333,{"lat":95,"lon":94},{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"New Zealand Clinical Research - Auckland","RECRUITING","Grafton","Auckland","1010","New Zealand","NZ",{"type":47,"coordinates":106},[107,108],174.76566,-36.86029,{"lat":108,"lon":107},[111,116],{"name":112,"role":34,"phone":113,"phoneExt":114,"email":115},"Emily Randell","+64 9 373 3474","7153","dream.auckland@nzcr.co.nz",{"name":117,"role":58,"phone":25,"phoneExt":25,"email":25},"Rohit Katial, MD",{"type":119,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638083","phase-1-diag723-in-adults-with-hereditary-hemorrhagic-telangiectasia-100638083",false,"NCT07623525","DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia","A Phase 1\u002F2, First-in-Human, Multicenter, Ascending Single-Dose and Multi-Dose Study to Assess the Safety of DIAG723, a Novel Bispecific ALK-1 and BMPRII Agonist Antibody in Adult Patients With Hereditary Hemorrhagic Telangiectasia (DIAMOND Trial)","DIAMOND","Inclusion Criteria:\n\n* Adult patients ≥18 years with a clinical or genetic diagnosis of HHT\n* Adequate hepatic and renal function\n* Part B: Epistaxis and anemia or transfusion\u002Firon history\n* Part C: HHT with documented pre-capillary pulmonary arterial hypertension\n\nExclusion Criteria:\n\n* Active or recent systemic infection\n* Recent thromboembolic events\n* Use of anti-angiogenic drugs within 6 weeks\n* Pregnancy or lactation\n* Recent participation in another investigational study","ALL","18 Years",{"count":131,"type":132},93,"ESTIMATED","INTERVENTIONAL",[135,136],"PHASE1","PHASE2","This is a Phase 1\u002F2, randomized, double-blind, placebo-controlled, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of subcutaneously administered DIAG723 in adult patients with hereditary hemorrhagic telangiectasia (HHT).\n\nThe study consists of three parts:\n\nPart A (dose escalation): Single ascending subcutaneous doses of DIAG723 are evaluated in sequential cohorts to assess safety, tolerability, and pharmacokinetics.\n\nPart B (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT to assess safety and preliminary efficacy.\n\nPart C (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT and concomitant pulmonary arterial hypertension to assess safety and exploratory clinical effects in this population.\n\nParticipants will be randomized within each study part to receive DIAG723 or placebo. The study includes dose escalation in Part A and dose expansion in Parts B and C.",[139,140],"Hereditary Hemorrhagic Telangiectasia","Pulmonary Arterial Hypertension",[139,142,143,144,145],"HHT","BMPRII","ALK1","Bone morphogenetic protein receptor type II","2026-06-30",{"date":148,"type":149},"2026-07-02","ACTUAL",{"date":151,"type":149},"2026-06-04",{"date":153,"type":132},"2027-12-31",{"name":5,"class":6},5]