[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657195":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":51,"studyPopulation":41,"armGroups":52,"interventions":69,"overallOfficials":79,"centralContacts":83,"locations":88,"responsibleParty":108,"collaborators":41,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":41,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":41,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":41,"overallStatus":91,"whyStopped":41,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"City Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)","To evaluate the safety and tolerability of single and multiple doses of CITY-RBP4 in healthy adults and participants with Stargardt disease Type 1 (STGD1)","Through study completion, up to Day 360",[14,18,22,24,26,28,30,32,34,38],{"measure":15,"description":16,"timeFrame":17},"Plasma concentrations of CITY-RBP4","To characterize the pharmacokinetic (PK) profile of CITY-RBP4 after single and multiple doses of CITY-RBP4 in healthy adults and participants with STGD1","Day 1 to Day 2",{"measure":19,"description":20,"timeFrame":21},"Urine concentrations of CITY-RBP4","To characterize the pharmacokinetic (PK) profile of CITY-RBP4 after a single dose of CITY-RBP4 in healthy adults and participants with STGD1","Part A and B only: Day 1 to Day 2",{"measure":23,"description":16,"timeFrame":17},"Maximum plasma concentration (Cmax)",{"measure":25,"description":16,"timeFrame":17},"Time to maximum plasma concentration (Tmax)",{"measure":27,"description":16,"timeFrame":17},"Area under plasma concentration-time curve (AUC)",{"measure":29,"description":16,"timeFrame":17},"Terminal elimination half-life (t1\u002F2)",{"measure":31,"description":16,"timeFrame":17},"Apparent clearance (CL\u002FF)",{"measure":33,"description":20,"timeFrame":21},"Amount excreted unchanged (Ae)",{"measure":35,"description":36,"timeFrame":37},"Change from baseline in plasma RBP4 concentrations","evaluate the pharmacodynamic (PD) effects of CITY-RBP4 on plasma retinol-binding protein 4 (RBP4) levels after single and multiple doses of CITY-RBP4 in healthy adults and participants with STGD1","Up to Day 360",{"measure":39,"description":40,"timeFrame":37},"Change from baseline in serum retinol concentrations","To evaluate the pharmacodynamic (PD) effects of CITY-RBP4 on serum retinol levels after single and multiple doses of CITY-RBP4 in healthy adults and participants with STGD1",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":48},"DOUBLE",[49,50],"PARTICIPANT","INVESTIGATOR","The study consists of 3 sequential parts:\n\n* Part A: Single-ascending doses in healthy volunteers\n* Part B: Single-ascending doses in participants with Stargardt Disease Type 1 (STGD1)\n* Part C: Multiple doses in participants with Stargardt Disease Type 1 (STGD1)",[53,58,63,66],{"label":54,"type":55,"description":41,"interventionNames":56},"CITY-RBP4 in Healthy Adults (Part A)","EXPERIMENTAL",[57],"Drug: CITY-RBP4",{"label":59,"type":60,"description":41,"interventionNames":61},"In Healthy Adults (Part A)","PLACEBO_COMPARATOR",[62],"Drug: Placebo",{"label":64,"type":55,"description":41,"interventionNames":65},"CITY-RBP4 in Participants with STGD1 (Parts B & C)",[57],{"label":67,"type":60,"description":41,"interventionNames":68},"In Participants with STGD1 (Parts B & C)",[62],[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":41},"DRUG","CITY-RBP4","siRNA (subcutaneous injection)",[54,64],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":41},"Placebo","Saline (subcutaneous injection)",[59,67],[80],{"name":81,"affiliation":5,"role":82},"Medical Director","STUDY_DIRECTOR",[84],{"name":5,"role":85,"phone":86,"phoneExt":41,"email":87},"CONTACT","857-219-5440","clinicaltrials@citytx.com",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Nucleus Network","RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":98,"coordinates":99},"Point",[100,101],144.96332,-37.814,{"lat":101,"lon":100},[104],{"name":105,"role":85,"phone":106,"phoneExt":41,"email":107},"Nucleus Network Melbourne","+61-1800-243-733","melbourne@nucleusnetwork.com",{"type":109,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100657195","phase-1-a-phase-1-first-in-human-study-of-city-rbp4-in-healthy-volunteers-and-stgd1-participants-100657195",false,"NCT07836452","A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants","A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single-Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-RBP4 Administered Subcutaneously in Healthy Volunteers and Participants With Stargardt Disease Type 1 (STGD1)","Key Inclusion Criteria (Part A):\n\n1. Willing and able to provide written informed consent form\n2. Be aged 18 to 45 years (inclusive) at the time of signing the informed consent form\n3. Generally healthy on medical history, exam, labs, and ECG\n4. BCVA 20\u002F25 or better in each eye\n5. Serum retinol above protocol threshold\n6. Body weight ≥40 kg and BMI of 18.0 to 32.0 kg\u002Fm2\n7. Men and WOCBP must agree to use highly effective methods of contraception or practice abstinence from 30 days before the first dose of CITY-RBP4, throughout the study, and for at least 180 days after treatment with CITY-RBP4 or the last study visit, whichever is longer; men must refrain from donating or banking sperm during the same period\n8. Female participants who are not WOCBP should meet at least 1 of the following criteria: have undergone a documented hysterectomy, bilateral oophorectomy, and\u002For bilateral salpingectomy; have medically confirmed ovarian failure, or achieved postmenopausal status\n\nKey Exclusion Criteria (Part A):\n\n1. Clinically significant ocular disease or prior ocular surgery that could interfere with safety assessments\n2. History of vitamin A deficiency, malabsorption, or chronic diarrhea\n3. Clinically significant cardiac, hepatic, renal, pulmonary, neurologic, or psychiatric disease\n4. Positive hepatitis B, hepatitis C, or HIV screening\n5. Prior RNAi\u002Foligonucleotide therapy or recent investigational treatment\n6. Recent vitamin A-related supplements, retinoids, or medications affecting vitamin A metabolism\n7. Pregnancy or breastfeeding, if applicable\n\nKey Inclusion Criteria (Parts B and C)\n\n1. Participants aged 12 to 45 years\n2. Clinical diagnosis of STGD1 with documented ABCA4 pathogenic\u002Flikely pathogenic variant\n3. Minimum BCVA is required in the study eye\n4. Subjects must have a defined aggregate atrophic lesion in 1 or both eyes\n5. Body weight ≥40 kg\n6. Able to complete key ophthalmic safety assessments and comply with study precautions\n\nKey Exclusion Criteria (Parts B and C)\n\n1. Ocular conditions that could confound retinal imaging or safety evaluation\n2. Prior ocular gene therapy, stem cell therapy, or retinal implant\n3. Vitamin A deficiency or recent prohibited vitamin A-related treatments\n4. Recent interventional study participation\n5. Clinically significant non-ophthalmic disease, abnormal screening labs\u002FECG, or positive hepatitis B, hepatitis C, or HIV screening\n6. Pregnancy or breastfeeding, if applicable",true,"ALL","12 Years","45 Years",{"count":122,"type":123},48,"ESTIMATED","INTERVENTIONAL",[126],"PHASE1","This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following single-ascending doses and multiple doses, via subcutaneous (SC) administration.",[129,130,131],"Stargardt Disease 1","STGD1","Healthy Volunteers","2026-09-22",{"date":134,"type":135},"2026-09-23","ACTUAL",{"date":137,"type":123},"2026-09",{"date":139,"type":123},"2028-04",{"name":5,"class":6},1]