[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379113":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","subjects entered into the trial may go thru a 0-4 weeks screening (Screening Phase). On the Intervention phase, subjects will be followed for 7 days which includes: entry criteria assessments and settling at the inpatient unit on Day 0, a single-dose I.V. infusion with data collection on Day 1 followed by 24 hours monitoring (Day 2), a 7-day and 28-day outpatient follow-up visit (Follow-Up Phase).",[13],"Biological: Fx-5A peptide complex",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Fx-5A peptide complex","subject will receive a slow I.V. infusion of the Fx-5A peptide complex as described in Table 1. Five to 10 mL of blood will be collected at 30min (+\u002F- 5min\\*), 1h (+\u002F- 10min\\*), 2h (+\u002F- 10min\\*), 4h (+\u002F- 15min\\*), 8h (+\u002F- 30min\\*), 12h (+\u002F- 30min\\*), and 24h (+\u002F- 30min\\*) for laboratory tests and to be stored for research tests. The patient will be dismissed, as inpatient, 24-36 hours after the beginning of the treatment.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Marcelo J Amar, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Joy Lynne V Freeman","CONTACT","(301) 480-7632","joylynne.freeman@nih.gov",{"name":23,"role":29,"phone":33,"phoneExt":20,"email":34},"(301) 402-0521","mamar@mail.nih.gov",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-77.10026,38.98067,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":54,"email":55},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY8664111010","prpl@cc.nih.gov",{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100379113","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-fx-5a-in-healthy-volunteers-100379113",false,"NCT04216342","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers","An Intravenous, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers","* INCLUSION CRITERIA:\n* 18 years of age or above\n* Women of childbearing potential must be willing to use an appropriate form of birth control during the course of the study and two forms of birth control during the interventional portion of the study and up to day 7 after infusion\n* Subject willing to return for all study visits, complete all study-related tasks, and agree not to participate in other research studies from screening visit to study completion\n* Willingness and capacity to provide written informed consent\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy (within the study period), or current breastfeeding\n* Subject taking any supplements or medications for at least 8 weeks prior to enrollment (with the exception of oral contraceptives).\n* Known allergies or intolerances to any components of the Fx-5A peptide-lipid complex\n* Known allergies or intolerances to eggs or egg components\n* History of febrile illness within 5 days prior to dosing\n* Hypertension (not treated or uncontrolled\\&)\n* BMI equal to or above 30 kg\u002Fm\\^2\n* Blood donation equal to or above 500 mL within 2 months prior to dosing.\n* Treatment with an investigational drug within a month or 5 half-lives of the investigational drug, whichever is longer, prior to dosing.\n* Laboratory changes (with CTCAE grade 2 or above): Abnormal levels of ALT, AST, CK, CRP, Alkaline Phosphatase, HbA1c, Urea, Creatinine, TSH, hemoglobin and hematocrit.\n* Subjects with renal (eGFR\\\u003C90 mL\u002Fmin \u002F1.73m\\^2) or liver impairment\n* Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data collection.",true,"ALL","18 Years","99 Years",{"count":70,"type":71},64,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","Background:\n\nHeart disease is the leading cause of death, disability, and healthcare expense in the United States. Researchers think a new drug called Fx-5A may be useful to treat different cardiovascular diseases and inflammation.\n\nObjective:\n\nTo understand the safety, tolerability, and effects of Fx-5A.\n\nEligibility:\n\nHealthy people ages 18 and older who are not pregnant\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test for female participants\n\nParticipants will stay in the hospital for 36-48 hours. This will include:\n\nBlood tests\n\nEKGs: Electrodes will be placed on the participant s chest. The patches are connected to cables that will send information from their heart to a machine.\n\nSingle infusion of Fx-5A. A needle will be used to insert a plastic tube into a vein in the participant s arm. This tube will remain in the arm for the duration of the hospital stay for blood tests.\n\nParticipants will have follow-up visits day 7 and day 28 after their infusion. At these visits, they will have blood tests and an EKG.\n\nParticipation will last 5-10 weeks.",[77],"Cardiovascular Disease",[79,80,81,82],"Pharmacology","PEPTIDE","ApoA-I","Fx-5A","2026-06-23",{"date":85,"type":86},"2026-06-24","ACTUAL",{"date":88,"type":86},"2021-09-29",{"date":90,"type":71},"2026-06-30",{"name":24,"class":6},1]