[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435804":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Megalabs","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Test rHuEpo in a single subcutaneous application.","EXPERIMENTAL","Group T: Test rHuEepo shall be administered subcutaneosly to study participants",[13,14],"Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU","Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU",{"label":16,"type":17,"description":18,"interventionNames":19},"Reference rHuEpo in a single subcutaneous application.","ACTIVE_COMPARATOR","Group T: Reference rHuEepo shall be administered subcutaneosly to study participants",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU","Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of the experimental drug should be administered subcutaneously",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU","Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Satish Kumar, MD","Azidus Principal Investigator","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Marcos Giusti, MD","CONTACT","+598926838000","mgiusti@megalabs.global",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Victoria Rodríguez, MD","vrodriguez@megalabs.global",[46],{"facility":47,"status":26,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Azidus Laboratories","Chennai","India","IN",{"type":52,"coordinates":53},"Point",[54,55],80.27847,13.08784,{"lat":55,"lon":54},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100435804","phase-1-biosimilarity-study-of-intravenous-recombinant-human-erythropoietin-in-healthy-volunteers-100435804",false,"NCT04954989","Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers","Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.","RUBI","Inclusion Criteria:\n\n* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (FICF) approved by the Research Ethics Committee (CEP);\n* Male participants aged between 18 and 55 years;\n* Be characterized as a healthy research participant, based on medical history, general physical examination and vital signs, laboratory tests and ECG not indicating any evidence of disease;\n* Present BMI ≥ 18 and ≤ 29.9 Kg\u002Fm2;\n* Have a body weight of 60 - 100 kg;\n* Present a negative test for coronavirus.\n\nExclusion Criteria:\n\n* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8°C), cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospital stay (all periods);\n* Having had direct and significant contact, at the medical discretion, with people who tested positive for a coronavirus test within 14 days prior to the hospital stay (all periods);\n* Living in the same household as people who fall into the risk group of worse prognosis for coronavirus infection, such as individuals over 60 years old, individuals with respiratory problems, immunosuppressed or those with chronic diseases such as heart or diabetes (all periods );\n* Any clinical condition or laboratory alteration that, at the investigator's discretion, may compromise trial participation, ie:\n* Have an abnormal erythrocyte count (\\\u003C4.0 M\u002Fmm3 or \\>5.4 M\u002Fmm3);\n* Have an abnormal reticulocyte count (\\> 3.0%);\n* Have an abnormal platelet count (\\\u003C 135,000\u002FμL or \\> 550,000\u002FμL);\n* Have an abnormal hemoglobin level (\\\u003C 13g\u002FdL);\n* Have an abnormal level of hematocrit (\\\u003C40% or \\>54%);\n* Have an abnormal level of ferritin (\\\u003C 100 ng\u002FmL or \\> 336.2 ng\u002FmL);\n* Have an abnormal level of transferrin (\\\u003C 200 mg\u002FdL or \\> 360 mg\u002FdL);\n* Have an abnormal level of transferrin saturation (\\\u003C20%)\n* Have abnormal levels of vitamin B12 (\\\u003C 130 pg\u002FmL or \\>868 pg\u002FmL);\n* Present evidence of cardiovascular disorders, particularly arterial hypertension (supine blood pressure \\> 145 \u002F 90mmHg at baseline);\n* History of venous thrombosis;\n* Participants diagnosed with iron deficiency anemia or clinical history of autoimmune or hereditary anemia;\n* Clinical history of chronic or acute hemorrhages in the 30 days preceding the start of the trial;",true,"MALE","18 Years","55 Years",{"count":72,"type":73},52,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population",[79],"Healthy",[81],"reticulocytes","NOT_YET_RECRUITING","2024-08-16",{"date":85,"type":86},"2024-08-21","ACTUAL",{"date":88,"type":73},"2024-10-06",{"date":90,"type":73},"2024-12",{"name":5,"class":6},1]