[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553858":3},{"organization":4,"armGroups":7,"interventions":73,"overallOfficials":79,"centralContacts":79,"locations":100,"responsibleParty":123,"collaborators":79,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":79,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":79,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":151,"whyStopped":79,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14,17,20,23,26,29,34,37,40,43,48,53,59,62,66,70],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A1-Cohort 1","EXPERIMENTAL","Participants will receive one single ascending dose of AZD4144.",[13],"Drug: AZD4144- Part A",{"label":15,"type":10,"description":11,"interventionNames":16},"Part A1- Cohort 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Part A1-Cohort 3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Part A2-Japanese cohort 1",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Part A2: Japanese Cohort 2",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Part A3-Chinese Cohort",[13],{"label":30,"type":10,"description":31,"interventionNames":32},"Part B1- Cohort 1","Participants will receive multiple ascending doses of AZD4144.",[33],"Drug: AZD4144- Part B",{"label":35,"type":10,"description":31,"interventionNames":36},"Part B1- Cohort 2",[33],{"label":38,"type":10,"description":31,"interventionNames":39},"Part B1- Cohort 3",[33],{"label":41,"type":10,"description":31,"interventionNames":42},"Part B2- Japanese Cohort",[33],{"label":44,"type":10,"description":45,"interventionNames":46},"Part C Cohort- Treatment C1","Participants will receive rosuvastatin and furosemide.",[47],"Drug: Rosuvastatin and Furosemide- Part C",{"label":49,"type":10,"description":50,"interventionNames":51},"Part C cohort- Treatment C2","Participants will receive rosuvastatin, furosemide, and AZD4144.",[52],"Drug: Rosuvastatin, Furosemide, and AZD4144 Part C",{"label":54,"type":55,"description":56,"interventionNames":57},"Part A1- Placebo","PLACEBO_COMPARATOR","Participants will receive matching placebo.",[58],"Drug: Placebo- Part A",{"label":60,"type":55,"description":56,"interventionNames":61},"Part A2- Placebo",[58],{"label":63,"type":55,"description":64,"interventionNames":65},"Part A3- Placebo","Participants will receive matching Placebo.",[58],{"label":67,"type":55,"description":64,"interventionNames":68},"Part B1- Placebo",[69],"Drug: Placebo- Part B",{"label":71,"type":55,"description":64,"interventionNames":72},"Part B2- Placebo",[69],[74,80,84,88,92,96],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"DRUG","AZD4144- Part A","Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.",[15,9,18,21,24,27],null,{"type":75,"name":81,"description":82,"armGroupLabels":83,"otherNames":79},"Placebo- Part A","Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.",[54,60,63],{"type":75,"name":85,"description":86,"armGroupLabels":87,"otherNames":79},"AZD4144- Part B","Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion.\n\nParticipants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.",[30,35,38,41],{"type":75,"name":89,"description":90,"armGroupLabels":91,"otherNames":79},"Placebo- Part B","Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion.",[67,71],{"type":75,"name":93,"description":94,"armGroupLabels":95,"otherNames":79},"Rosuvastatin and Furosemide- Part C","Participants will be administered a single oral dose of 10 mg Rosuvastatin and 1 mg Furosemide.",[44],{"type":75,"name":97,"description":98,"armGroupLabels":99,"otherNames":79},"Rosuvastatin, Furosemide, and AZD4144 Part C","Participants will be administered a single oral dose of 10 mg Rosuvastatin, 1 mg Furosemide and a single dose of AZD4144 via IV infusion.",[49],[101,114],{"facility":102,"status":79,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":79},"Research Site","Glendale","California","91206","United States","US",{"type":109,"coordinates":110},"Point",[111,112],-118.25508,34.14251,{"lat":112,"lon":111},{"facility":102,"status":79,"city":115,"state":116,"zip":117,"country":106,"countryCode":107,"cosmosGeoPoint":118,"geoPoint":122,"contacts":79},"Brooklyn","Maryland","21225",{"type":109,"coordinates":119},[120,121],-76.60219,39.23039,{"lat":121,"lon":120},{"type":124,"investigatorFullName":79,"investigatorTitle":79,"investigatorAffiliation":79,"oldNameTitle":79,"oldOrganization":79},"SPONSOR","100553858","phase-1-a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4144-as-well-as-the-impact-of-azd4144-on-the-pharmacokinetics-of-rosuvastatin-and-furosemide-in-healthy-participants-100553858",false,"NCT06491550","A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants","A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants","Inclusion Criteria:\n\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.\n* Females of non-childbearing potential must be confirmed at the Screening Visit.\n* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.\n* Have a BMI between 18 and 32 kg\u002Fm2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.\n* For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.\n* For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma.\n* Clinically significant serious active and chronic infections.\n* Any history or evidence of TB (active or latent).\n* Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.\n* Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.\n* Any abnormal laboratory values at the Screening Visit or on Admission to the Clinical Unit.\n* Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).\n* Any clinically important abnormalities in ECG.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity.\n* Known hypersensitivity to furosemide and rosuvastatin (for Part C only)\n* History of alcohol abuse or excessive intake of alcohol or current smokers or those who have smoked or used nicotine products.\n* Use of drugs with enzyme inducing properties or of any prescribed or nonprescribed medication or of systemic hormonal contraceptives.\n* Clinical signs and symptoms consistent with COVID-19.",true,"ALL","18 Years","55 Years",{"count":137,"type":138},91,"ACTUAL","INTERVENTIONAL",[141],"PHASE1","This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144",[144],"Healthy Participants",[146,147,148,149,150],"Pharmacokinetic (PK)","Pharmacodynamic (PD)","Drug-drug interaction (DDI)","Single ascending dose (SAD)","Multiple ascending dose (MAD)","COMPLETED","2025-07-03",{"date":154,"type":138},"2025-07-04",{"date":156,"type":138},"2024-07-15",{"date":158,"type":138},"2025-06-11",{"name":5,"class":6},2]