[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570977":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":93,"collaborators":30,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":30,"enrollmentInfo":105,"targetDuration":30,"studyType":108,"phases":109,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"RiboX Therapeutics Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"RXRG001 Part 1","EXPERIMENTAL","Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral)",[13],"Biological: RXRG001",{"label":15,"type":10,"description":16,"interventionNames":17},"RXRG001 Part 2","Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo Part 2","PLACEBO_COMPARATOR","Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)",[23],"Biological: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","RXRG001","Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","Placebo (saline)",[19],[36],{"name":5,"role":37,"phone":38,"phoneExt":30,"email":39},"CONTACT","617-999-8257","RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com",[41,58,70,81],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Iowa Hospitals and Clinics","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-91.53017,41.66113,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":30,"phoneExt":30,"email":30},"Principal Investigator",{"facility":59,"status":43,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"John Hopkins University, Sidney Kimmel Comprehensive Cancer Center","Baltimore","Maryland","21287",{"type":50,"coordinates":64},[65,66],-76.61219,39.29038,{"lat":66,"lon":65},[69],{"name":57,"role":37,"phone":30,"phoneExt":30,"email":30},{"facility":71,"status":43,"city":72,"state":72,"zip":73,"country":47,"countryCode":48,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"NYU Langone Medical Center","New York","10016-6402",{"type":50,"coordinates":75},[76,77],-74.00597,40.71427,{"lat":77,"lon":76},[80],{"name":57,"role":37,"phone":30,"phoneExt":30,"email":30},{"facility":82,"status":43,"city":83,"state":84,"zip":85,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman","Philadelphia","Pennsylvania","19104",{"type":50,"coordinates":87},[88,89],-75.16362,39.95238,{"lat":89,"lon":88},[92],{"name":57,"role":37,"phone":30,"phoneExt":30,"email":30},{"type":94,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100570977","phase-1-study-of-circular-rna-treatment-in-patients-with-radiation-induced-xerostomia-1-100570977",false,"NCT06714253","Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1","A Phase I\u002FIIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation","SPRINX-1","Inclusion Criteria\\*\n\n1. At least 18 years of age\n2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years\n3. Suffering from xerostomia and\u002For hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months\n4. Both parotid glands on imaging examination\n\nExclusion Criteria\\*\n\n1. Any active infection\n2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \\>=8%)\n3. History of autoimmune diseases known to potentially affect the salivary glands\n4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers\n5. Active smoker or use tobacco products or have a history of substance or alcohol abuse\n\n   * Other criteria apply","ALL","18 Years",{"count":106,"type":107},42,"ESTIMATED","INTERVENTIONAL",[110,111],"PHASE1","PHASE2","This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production).\n\nIn Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts.\n\nPart 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.",[114],"Radiation-Induced Xerostomia and Hyposalivation",[116,117,118,119,120],"Radiation Induced Xerostomia","First-in-human","Hyposalivation","Circular ribonucleic acid","Aquaporin 1","2026-07-28",{"date":123,"type":124},"2026-07-29","ACTUAL",{"date":126,"type":124},"2025-03-05",{"date":128,"type":107},"2027-08",{"name":5,"class":6},4]