[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339346":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ASP5354 Dose Escalation (5 Dose Levels)","EXPERIMENTAL","Healthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, 4 subjects will be randomized to receive escalated doses of ASP5354. Each subject will receive a single intravenous bolus injection under fasting conditions.",[13],"Drug: ASP5354",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Dose Escalation (5 Dose Levels)","PLACEBO_COMPARATOR","Healthy male and female subjects will be assigned to Cohorts 1-5. In each cohort, two subjects will be randomized to receive placebo.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ASP5354","Intravenous",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31],{"name":32,"affiliation":33,"role":34},"Medical Monitor","Astellas Pharma Global Development, Inc.","STUDY_DIRECTOR",[36],{"facility":37,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Covance CRU, Daytona Beach","Daytona Beach","Florida","32117","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.02283,29.21081,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100339346","phase-1-a-study-in-healthy-adult-volunteers-to-assess-the-safety-and-pharmacokinetics-of-an-investigational-imaging-product-100339346",false,"NCT03698305","A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product","A Double-blinded, Randomized, Controlled, Single Ascending Dose Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product","Inclusion Criteria:\n\n* A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP). OR\n  * A WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 30 days after the final investigational product (IP) administration.\n* Female subject must agree not to breastfeed starting at screening, throughout the study period and for 30 days after the final IP administration.\n* Female subject must not donate ova starting at screening, throughout the study period and for 30 days after the final IP administration.\n* Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 30 days after the final IP administration.\n* Male subject must not donate sperm during the treatment period and for at least 30 days after the final IP administration.\n* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom with spermicide for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for 30 days after the final IP administration.\n* Subject agrees not to participate in another interventional study while participating in the present study.\n* Subject has a body mass index range of 18.5 to 32.0 kg\u002Fm2, inclusive, and weighs \\> 50 kg (for males) or \\> 40 kg (for females) at screening.\n\nExclusion Criteria:\n\n* Subject has signs of urinary tract infection, abnormalities or disease or has had operational interventions on the urinary tract.\n* Subject has received any IP within 28 days or 5 half-lives (if known), whichever is longer, prior to screening.\n* Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.\n* Subject has a known or suspected hypersensitivity to ASP5354 or any components of the formulation used.\n* Subject has had previous exposure to ASP5354.\n* Subject has any of the liver function tests (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], alkaline phosphatase, gamma glutamyl transferase and total bilirubin \\[TBL\\]) \\> upper limit of normal (ULN) at day -1.\n* Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to IP administration.\n* Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and\u002For other major disease or malignancy.\n* Subject has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 2 weeks prior to day -1.\n* Subject has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or day 1.\n* Subject has a mean pulse \\\u003C 45 bpm or \\> 90 bpm, mean systolic blood pressure \\> 140 mmHg or mean diastolic blood pressure \\> 90 mmHg at day -1.\n* Subject has a mean corrected QT interval using Fridericia's formula (QTcF) \\> 430 msec (for males) and \\> 450 msec (for females) at day 1 (as determined by the ECG machine). If the mean QTcF exceeds the limits above, 1 additional triplicate (3 measurements) ECG can be taken.\n* Subject has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives, hormone replacement therapy or natural and herbal remedies \\[e.g., St. John's Wort\\]) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g\u002Fday) or topical dermatological products, including corticosteroid products.\n* Subject has smoked or has used tobacco-containing products or nicotine or nicotine containing products in the past 6 months prior to screening or the subject tests positive for cotinine at screening or day -1.\n* Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug\u002Fchemical\u002Fsubstance abuse within the past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits\u002Fhard liquor).\n* Subject has used any drugs of abuse (including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 3 months prior to day -1 or the subject tests positive for alcohol or drugs of abuse (including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or day -1.\n* Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.\n* Subject has had significant blood loss, donated 1 unit (450 mL) or more of blood or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day -1.\n* Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies or human immunodeficiency virus p24 antigen at screening.\n* Subject has any of the renal function tests (blood urea nitrogen and creatinine) \\> ULN at day -1.\n\nIn such a case, the assessment may be repeated once.",true,"ALL","18 Years","55 Years",{"count":63,"type":64},30,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.",[70],"Healthy Subjects",[72,73,74,23],"Tolerability","Pharmacokinetics","Safety","COMPLETED","2024-10-15",{"date":78,"type":64},"2024-10-16",{"date":80,"type":64},"2018-10-25",{"date":82,"type":64},"2019-05-20",{"name":33,"class":6},1]