[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625928":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Akebia Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: AKB-9090",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Single IV dose of matching Placebo.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AKB-9090 will be administered intravenously",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Matching Placebo administered intravenously",[15],[31],{"name":32,"affiliation":33,"role":34},"Dr. Leanne Barnett, Leanne.barnett@nzcr.co.nz","New Zealand Clinical Research (NZCR)","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Dr. Leanne Barnett","CONTACT","+64 9 373 3474","propeller.auckland@nzcr.co.nz",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Investigator Site #1","RECRUITING","Auckland","New Zealand","NZ",{"type":49,"coordinates":50},"Point",[51,52],174.76349,-36.84853,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[57],{"name":58,"class":59},"Emerald Clinical Trials","UNKNOWN","100625928","phase-1-sad-and-mad-study-of-akb-9090-in-healthy-adult-participants-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":72,"type":73},70,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79],"Healthy Volunteers",[9,81,82,83,84,85,86,87,88,79],"Single-centre","Single Ascending Dose","Multiple Ascending Dose","First-in-human","Safety","Tolerability","Randomized","Double-blind","2026-04-07",{"date":91,"type":92},"2026-04-13","ACTUAL",{"date":94,"type":92},"2026-03-16",{"date":96,"type":73},"2026-12",{"name":5,"class":6},1]