[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613260":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":70,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Consano Bio","INDUSTRY",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 - Low dose","EXPERIMENTAL",null,[13,14],"Drug: C-1101","Other: Placebo: Sterile Saline",{"label":16,"type":10,"description":11,"interventionNames":17},"Cohort 2 - Mid dose",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort 3 - High dose",[13,14],[22,26],{"type":23,"name":24,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","C-1101",[9,16,19],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"OTHER","Placebo: Sterile Saline","Placebo",[9,16,19],[32],{"name":33,"affiliation":5,"role":34},"Consano Chief Medical Officer","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Senior Director, Clinical Development Operations","CONTACT","AUS: +61 (1800) 057510","clindev@consanobio.com",[42,55,62],{"facility":43,"status":44,"city":45,"state":46,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":11},"Consano Bio Research Site","RECRUITING","Broadmeadow","New South Wales","Australia","AU",{"type":50,"coordinates":51},"Point",[52,53],151.72849,-32.92371,{"lat":53,"lon":52},{"facility":43,"status":44,"city":56,"state":46,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":57,"geoPoint":61,"contacts":11},"Wahroonga",{"type":50,"coordinates":58},[59,60],151.11561,-33.71816,{"lat":60,"lon":59},{"facility":43,"status":44,"city":63,"state":64,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":11},"Melbourne","Victoria",{"type":50,"coordinates":66},[67,68],144.96332,-37.814,{"lat":68,"lon":67},{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100613260","phase-1-study-to-evaluate-safety-of-c-1101-versus-sterile-saline-in-adults-with-chronic-painful-lumbosacral-radiculopathy-100613260",false,"NCT07264270","Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy","A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy","Inclusion Criteria:\n\n* Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care\n* Body mass index \\\u003C 35 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Presence of clinically significant disease or any other painful condition that may interfere with assessments.\n* Any condition that currently requires blood or platelet transfusions.\n* Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.\n* Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors.\n* History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies.\n* History of myocardial infarction within the last 6 months or congestive heart failure.\n* The presence of an active malignancy or tumor.\n* Have undergone a surgical procedure for back pain.\n* Recent use of immunosuppressants, oral steroids, or intravenous steroids.","ALL","18 Years","65 Years",{"count":83,"type":84},24,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline",[90,91,92,93,94,95],"Lumbosacral Radicular Pain","Sciatic Radiculopathy","Sciatic Leg Pain","Sciatica","Lumbosacral Radicular Syndrome","Lumbosacral Radiculopathy",[93,97,98,99,95,100,101,102],"Sciatic Nerve Pain","LSR","back pain","Chronic Painful Lumbosacral Radiculopathy","non-opioid pain medication","transforaminal epidural injection","2026-03-16",{"date":105,"type":106},"2026-03-17","ACTUAL",{"date":108,"type":106},"2025-12-03",{"date":110,"type":84},"2026-12-01",{"name":5,"class":6},3]