[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642082":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":66,"centralContacts":71,"locations":77,"responsibleParty":91,"collaborators":45,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":45,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":45,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":79,"whyStopped":45,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Cajal Therapeutics Inc.","INDUSTRY",[8,14,20,25,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Ascending Dose (CTX001)","EXPERIMENTAL","Up to 5 sequential, single ascending dose cohorts.",[13],"Drug: CTX001 With and Without Iron",{"label":15,"type":16,"description":17,"interventionNames":18},"Single Ascending Dose (Placebo)","PLACEBO_COMPARATOR","Up to 5 sequential, single ascending dose cohorts",[19],"Drug: Placebo With and Without Iron",{"label":21,"type":10,"description":22,"interventionNames":23},"Food Effect (CTX001)","Up to 3 sequential, single ascending dose food effect cohorts",[24],"Drug: CTX001 With Iron",{"label":26,"type":16,"description":22,"interventionNames":27},"Food Effect (Placebo)",[28],"Drug: Placebo With Iron",{"label":30,"type":10,"description":31,"interventionNames":32},"Multiple Ascending Dose (CTX001)","Up to 3 multiple ascending dose cohorts.",[33],"Drug: CTX001 Multiple Dose",{"label":35,"type":16,"description":36,"interventionNames":37},"Multiple Ascending Dose (Placebo)","Up to 3 multiple ascending dose cohorts",[38],"Drug: Placebo Multiple Dose",[40,46,50,54,58,62],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","CTX001 With and Without Iron","There are two treatment periods. In the first, CTX001 is administered as a single dose (tablet) by itself. In the second, CTX001 is administered as a single dose (tablet) with iron.",[9],null,{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":45},"CTX001 With Iron","There are two treatment periods. In one, CTX001 is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, CTX001 is administered as a single dose (tablet) with iron (tablet) under fasting conditions.",[21],{"type":41,"name":51,"description":52,"armGroupLabels":53,"otherNames":45},"CTX001 Multiple Dose","CTX001 (tablet) is administered daily for 7 consecutive days.",[30],{"type":41,"name":55,"description":56,"armGroupLabels":57,"otherNames":45},"Placebo With and Without Iron","There are two treatment periods. In the first, placebo is administered as a single dose (tablet) by itself. In the second, placebo is administered as a single dose (tablet) with iron.",[15],{"type":41,"name":59,"description":60,"armGroupLabels":61,"otherNames":45},"Placebo With Iron","There are two treatment periods. In one, placebo is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, placebo is administered as a single dose (tablet) with iron (tablet) under fasting conditions.",[26],{"type":41,"name":63,"description":64,"armGroupLabels":65,"otherNames":45},"Placebo Multiple Dose","Placebo (tablet) is administered daily for 7 consecutive days.",[35],[67],{"name":68,"affiliation":69,"role":70},"Aarthy Joseph, Dr","Nucleus Network","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":45,"email":76},"Anthony Johnson","CONTACT","+61 07 3707 2787","a.johnson@nucleusnetwork.com.au",[78],{"facility":69,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":45},"RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":86,"coordinates":87},"Point",[88,89],144.96332,-37.814,{"lat":89,"lon":88},{"type":92,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100642082","early-phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ctx001-in-healthy-adults-100642082",false,"NCT07577817","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.","A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Agrees to use effective contraception\n* Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm2\n* Healthy by medical evaluation and medical history\n* Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%\n* Can swallow tablets and has suitable venous access for blood sampling\n\nExclusion Criteria:\n\n* Has dietary requirements that may be difficult to accommodate\n* Is a regular user of cannabis or has a history of illicit drug abuse within 1 year\n* Has a history of alcohol abuse or binge drinking within 6 months\n* Is a regular user of tobacco or nicotine-containing products\n* Unwilling or unable to comply with the lifestyle guidelines described in the protocol\n* Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator\n* Has any concurrent disease or condition or physical, psychological, mental, and\u002For social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study\n* Has received a blood transfusion within 1 year\n* Has donated whole blood within 6 months or plasma within 30 days\n* Requires prescription medication or regular use of non-prescription medication\n* Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study",true,"ALL","18 Years","55 Years",{"count":105,"type":106},72,"ESTIMATED","INTERVENTIONAL",[109],"EARLY_PHASE1","This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and\u002For food.",[112,113,114],"Anemia","Iron Deficiencies","Chronic Kidney Disease",[116,117,112,118],"Red blood cells","Iron","Chronic kidney disease","2026-06-10",{"date":121,"type":122},"2026-06-12","ACTUAL",{"date":124,"type":106},"2026-06",{"date":126,"type":106},"2026-12-30",{"name":5,"class":6},1]