[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625928":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":11,"studyPopulation":11,"armGroups":83,"interventions":96,"overallOfficials":105,"centralContacts":110,"locations":116,"responsibleParty":129,"collaborators":131,"id":135,"slug":11,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":11,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":11,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":119,"whyStopped":11,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Akebia Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":11},[9,13,15,17,19,21,24,26,28],{"measure":10,"description":11,"timeFrame":12},"Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs",null,"From First Dose to Day 7",{"measure":14,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Physical Examinations",{"measure":16,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Vital Signs",{"measure":18,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)",{"measure":20,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Chemistry parameters",{"measure":22,"description":11,"timeFrame":23},"Number of Participants with Clinically Significant Changes in Hematology Parameters","from first dose to Day 7",{"measure":25,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Lipid Parameters",{"measure":27,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Coagulation Parameters",{"measure":29,"description":11,"timeFrame":12},"Number of Participants with Clinically Significant Changes in Urinalysis Parameters",[31,34,36,38,40,42,44,47,49,51,53,55,58,61,64,66,69,72],{"measure":32,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090","At Day 1",{"measure":35,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090",{"measure":37,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090",{"measure":39,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090",{"measure":41,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090",{"measure":43,"description":11,"timeFrame":33},"Stage 1 SAD Cohorts: Terminal half-life (T1\u002F2) of AKB-9090",{"measure":45,"description":11,"timeFrame":46},"Stage 2 MAD Cohorts: Cmax of AKB-9090","At Day 1 and Day 7",{"measure":48,"description":11,"timeFrame":46},"Stage 2 MAD Cohorts: Tmax of AKB-9090",{"measure":50,"description":11,"timeFrame":33},"Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090",{"measure":52,"description":11,"timeFrame":46},"Stage 2 MAD Cohorts: CL of AKB-9090",{"measure":54,"description":11,"timeFrame":46},"Stage 2 MAD Cohorts: T1\u002F2 of AKB-9090",{"measure":56,"description":11,"timeFrame":57},"Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090","At Day 7",{"measure":59,"description":11,"timeFrame":60},"Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO)","Baseline (Day 1) and at 6, 12, 18, and 24 hours post-dose",{"measure":62,"description":11,"timeFrame":63},"Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Red Blood Cell Count (RBC)","Baseline (Day 1) and At Day 2",{"measure":65,"description":11,"timeFrame":63},"Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count",{"measure":67,"description":11,"timeFrame":68},"Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO","Baseline (Day 1 and Day 7) and at 6, 12, 18, and 24 hours post-dose",{"measure":70,"description":11,"timeFrame":71},"Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - RBC","Baseline (Day 1) and At Days 4 and 8",{"measure":73,"description":11,"timeFrame":71},"Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count",{"allocation":75,"interventionModel":76,"interventionModelDescription":11,"primaryPurpose":77,"observationalModel":11,"timePerspective":11,"maskingInfo":78},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":79,"maskingDescription":11,"whoMasked":80},"DOUBLE",[81,82],"PARTICIPANT","INVESTIGATOR",[84,90],{"label":85,"type":86,"description":87,"interventionNames":88},"AKB-9090","EXPERIMENTAL","Participants will receive a single intravenous (IV) dose of AKB-9090 at 5 escalating dose levels in the SAD stage and at 3 dose levels in the MAD stage.",[89],"Drug: AKB-9090",{"label":91,"type":92,"description":93,"interventionNames":94},"Placebo","PLACEBO_COMPARATOR","Single IV dose of matching Placebo.",[95],"Other: Placebo",[97,101],{"type":98,"name":85,"description":99,"armGroupLabels":100,"otherNames":11},"DRUG","AKB-9090 will be administered intravenously",[85],{"type":102,"name":91,"description":103,"armGroupLabels":104,"otherNames":11},"OTHER","Matching Placebo administered intravenously",[91],[106],{"name":107,"affiliation":108,"role":109},"Dr. Leanne Barnett, Leanne.barnett@nzcr.co.nz","New Zealand Clinical Research (NZCR)","STUDY_DIRECTOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":11,"email":115},"Dr. Leanne Barnett","CONTACT","+64 9 373 3474","propeller.auckland@nzcr.co.nz",[117],{"facility":118,"status":119,"city":120,"state":11,"zip":11,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":11},"Investigator Site #1","RECRUITING","Auckland","New Zealand","NZ",{"type":124,"coordinates":125},"Point",[126,127],174.76349,-36.84853,{"lat":127,"lon":126},{"type":130,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[132],{"name":133,"class":134},"Emerald Clinical Trials","UNKNOWN","100625928",false,"NCT07429006","SAD and MAD Study of AKB-9090 in Healthy Adult Participants","A Randomized, Double-Blind, Placebo-Controlled, Single (SAD) and Multiple Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AKB-9090 Administered Intravenously to Healthy Adult Participants","Key Inclusion Criteria:\n\n* Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and urinalysis).\n* Body mass index (BMI) greater than 18.5 and less than 32.0 kg\u002Fm\\^2 at screening.\n* In the Investigator's opinion, willing and able to provide written informed consent and comply with the all protocol requirements, including required confinement, outpatient visits, and protocol-specified restrictions (including refraining from major lifestyle changes) from signature of the informed consent form (ICF) through the last study visit.\n\nKey Exclusion Criteria:\n\n* Clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatologic, urogenital, ophthalmologic, ear\u002Fnose\u002Fthroat, psychiatric, or neurologic disorder.\n* History of active or recurrent malignancy within 2 years before screening or during the screening period, or currently receiving treatment or suppressive therapy for cancer, except for:\n\n  1. Treated basal cell carcinoma of the skin\n  2. Curatively resected squamous cell carcinoma of the skin\n  3. Treated colonic or cervical carcinoma in situ\n* Abnormal ECG findings at screening, including:\n\n  1. Severe bradycardia (heart rate \\\u003C40 beats per minute) on any measurement\n  2. Mean QT Interval Using Fridericia's Formula (QTcF) \\>450 msec for males or \\>470 msec for females\n* Elevated laboratory values (\\>1.25 × upper limit of normal \\[ULN\\]) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine at the screening visit or at check-in.\n* Evidence of acute or chronic hepatitis B (positive hepatitis B surface antigen) or hepatitis C infection (positive hepatitis C antibody and positive hepatitis C ribonucleic acid \\[RNA\\] test).\n* Use of nicotine-containing products (including cigarettes, cigars, tobacco, gum, patches, vaping, and e-cigarettes), caffeine-containing foods or beverages, and alcohol-containing foods or beverages during study.",true,"ALL","18 Years","60 Years",{"count":146,"type":147},70,"ESTIMATED","INTERVENTIONAL",[150],"PHASE1","This is a first-in-human (FIH study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of AKB-9090 in healthy adult participants. The study consists of two stages: Stage 1, a single ascending dose (SAD) phase with five dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with three dose cohorts. Approximately 40 participants in SAD and 30 in MAD are planned to be enrolled.",[153],"Healthy Volunteers",[85,155,156,157,158,159,160,161,162,153],"Single-centre","Single Ascending Dose","Multiple Ascending Dose","First-in-human","Safety","Tolerability","Randomized","Double-blind","2026-04-07",{"date":165,"type":166},"2026-04-13","ACTUAL",{"date":168,"type":166},"2026-03-16",{"date":170,"type":147},"2026-12",{"name":5,"class":6},1]