[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624330":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":20,"studyPopulation":11,"armGroups":21,"interventions":44,"overallOfficials":11,"centralContacts":62,"locations":68,"responsibleParty":113,"collaborators":11,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":11,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":11,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Octant, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and tolerability of multiple doses (Phase 1b\u002F2) of OCT-980 in participants with a genetic diagnosis of RHO-adRP.",null,"Time Frame: From Baseline to Week 60 (Ph 1b\u002F2)",{"allocation":14,"interventionModel":15,"interventionModelDescription":16,"primaryPurpose":17,"observationalModel":11,"timePerspective":11,"maskingInfo":18},"NON_RANDOMIZED","SEQUENTIAL","Phase 1b\u002F2 in RHO-adRP participants is being conducted in the US.","TREATMENT",{"masking":19,"maskingDescription":11,"whoMasked":11},"NONE","Octant, Inc. is evaluating OCT-980, an oral small molecule corrector for the treatment of patients with rhodopsin (RHO)-associated autosomal dominant retinitis pigmentosa (RHO-adRP). There is no known cure and no currently approved therapy for RHO-adRP, a disease of the retina characterized by progressive loss of vision.\n\nThis study is comprised of a Phase 1a in healthy volunteers, which was conducted in Australia and is now complete.\n\nThe phase 1b\u002F2 study is an open-label, multi-center multiple ascending dose escalation (MAD) to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of multiple-ascending doses of OCT-980 for up to 48 weeks, in participants with a genetic diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa (RP).\n\nRHO-adRP participants are currently being recruited for the phase 1b\u002F2 study in the US.",[22,28,32,36,40],{"label":23,"type":24,"description":25,"interventionNames":26},"Phase 1b\u002F2: OCT-980 Cohort 1","EXPERIMENTAL","OCT-980 tablets administered orally once daily.",[27],"Drug: Phase 1b\u002F2: Cohort 1 - OCT-980 Tablet",{"label":29,"type":24,"description":25,"interventionNames":30},"Phase 1b\u002F2: OCT-980 Cohort 2",[31],"Drug: Phase 1b\u002F2: Cohort 2 - OCT-980 Tablet",{"label":33,"type":24,"description":25,"interventionNames":34},"Phase 1b\u002F2: OCT-980 Cohort 3",[35],"Drug: Phase 1b\u002F2: Cohort 3 - OCT-980 Tablet",{"label":37,"type":24,"description":25,"interventionNames":38},"Phase 1b\u002F2: OCT-980 Cohort 4",[39],"Drug: Phase 1b\u002F2: Cohort 4 - OCT-980 Tablet",{"label":41,"type":24,"description":25,"interventionNames":42},"Phase 1b\u002F2: OCT-980 Cohort 5",[43],"Drug: Phase 1b\u002F2: Cohort 5 - OCT-980 Tablet",[45,50,53,56,59],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"DRUG","Phase 1b\u002F2: Cohort 1 - OCT-980 Tablet","OCT-980 tablets administered orally once daily at dose levels specified in the protocol",[23],{"type":46,"name":51,"description":48,"armGroupLabels":52,"otherNames":11},"Phase 1b\u002F2: Cohort 2 - OCT-980 Tablet",[29],{"type":46,"name":54,"description":48,"armGroupLabels":55,"otherNames":11},"Phase 1b\u002F2: Cohort 3 - OCT-980 Tablet",[33],{"type":46,"name":57,"description":48,"armGroupLabels":58,"otherNames":11},"Phase 1b\u002F2: Cohort 4 - OCT-980 Tablet",[37],{"type":46,"name":60,"description":48,"armGroupLabels":61,"otherNames":11},"Phase 1b\u002F2: Cohort 5 - OCT-980 Tablet",[41],[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Octant adRP Clinical Operations","CONTACT","+1-510-500-5956","adrpclinicaltrials@octant.bio",[69,94],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Casey Eye Institute","RECRUITING","Portland","Oregon","97239","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-122.67621,45.52345,{"lat":81,"lon":80},[84,88,91],{"name":85,"role":65,"phone":86,"phoneExt":11,"email":87},"Brian Heimdahl, BA","503-494-9771","heimdahb@ohsu.edu",{"name":89,"role":65,"phone":11,"phoneExt":11,"email":90},"Aidan Flieger","flieger@ohsu.edu",{"name":92,"role":93,"phone":11,"phoneExt":11,"email":11},"Lesley Everett, MD","PRINCIPAL_INVESTIGATOR",{"facility":95,"status":71,"city":96,"state":97,"zip":98,"country":75,"countryCode":76,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Retina Foundation of the Southwest","Dallas","Texas","75231-5080",{"type":78,"coordinates":100},[101,102],-96.80667,32.78306,{"lat":102,"lon":101},[105,108,111],{"name":106,"role":65,"phone":11,"phoneExt":11,"email":107},"Charlene Nwajei","cnwajei@retinafoundation.org",{"name":109,"role":65,"phone":11,"phoneExt":11,"email":110},"Jennifer Herrera","jherrera@retinafoundation.org",{"name":112,"role":93,"phone":11,"phoneExt":11,"email":11},"Mark Pennesi, MD",{"type":114,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624330","phase-1-a-phase-12-study-in-healthy-volunteers-and-participants-with-autosomal-dominant-retinitis-pigmentosa-rho-adrp-100624330",false,"NCT07408232","A Phase 1\u002F2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of OCT-980 in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa","Phase 1b\u002F2 is active. Inclusion\n\nPhase 1b\u002F2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Inclusion:\n\n* Participants must have a diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa confirmed by a genetic test that is implemented in accordance with the relevant national requirements\n* Male or female greater than or equal to age 18 (inclusive) at the time of signing the informed consent form\n* Have a body weight \\>50kg, with a body mass index (BMI) from 18.0 to 35.0 kg\u002Fm\\^2 (inclusive) at screening\n* Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) \\> 55\n* Other than their diagnosis of RHO-adRP, be in good general health, as determined by the Investigator\n* Have sufficient venous access to allow blood sampling for pharmacokinetic analysis and safety laboratory samples\n\nPhase 1b\u002F2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Exclusion:\n\n* Females who are pregnant or breastfeeding\n* Evidence of any other significant ocular (other than RHO-adRP) and non-ocular disease\u002F disorder\n* Lifetime history of ocular surgery\n* Any prior or current ophthalmologic gene therapy\n* Has a history of major surgery, severe trauma, or bone fracture within 12 weeks before the first dose of the investigational product or planned surgery within 4 weeks after the end of the study","ALL","18 Years",{"count":125,"type":126},18,"ESTIMATED","INTERVENTIONAL",[129,130],"PHASE1","PHASE2","This integrated Ph1\u002F2 clinical study is to assess the safety, tolerability and pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of OCT-980 in healthy volunteers and participants with RHO-adRP.",[133],"Retinitis Pigmentosa",[135,136,133,137,138,139,140,141,142],"Rhodopsin-associated autosomal dominant Retinitis Pigmentosa","RHO-adRP","Inherited Retinal Disease","autosomal dominant Retinitis Pigmentosa","Retinitis Pigmentosa 4","RP4","RP","Eye Diseases","2026-09-22",{"date":145,"type":146},"2026-09-24","ACTUAL",{"date":148,"type":146},"2026-03-10",{"date":150,"type":126},"2028-11-01",{"name":5,"class":6},2]