[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631073":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HLX319 arm","EXPERIMENTAL","subjects will receive a single subcutaneous injection of HLX319.",[13],"Drug: HLX319",{"label":15,"type":16,"description":17,"interventionNames":18},"Eu-Phesgo arm","ACTIVE_COMPARATOR","subjects will receive a single subcutaneous injection of Eu-Phesgo.",[19],"Drug: EU-Phesgo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","HLX319","HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"EU-Phesgo","EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"qi Jin","CONTACT","86 159 5516 0489","Qi_jin@henlius.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Anhui Medical University Second Affiliated Hospital","Hefei","Anhui","230601","China","CN",{"type":46,"coordinates":47},"Point",[48,49],117.28083,31.86389,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Wei Hu, Dr","0551-65997164","hwgcp@ayefy.com",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631073","phase-1-pharmacokinetic-characteristics-safety-and-immunogenicity-of-hlx319-compared-with-eu-phesgo-100631073",false,"NCT07495930","Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®","A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.","Inclusion Criteria:\n\n1. Male subjects aged ≥18 and ≤45 years;\n2. The skin at the injection site is intact, without damage, tattoos, or other markings;\n3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;\n4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.\n5. Body weight (BW) ≥50 and ≤75 kg;\n6. Body mass index (BMI) ≥19 and ≤24 kg\u002Fm² \\[BMI = weight (kg) \u002F height² (m²)\\];\n7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);\n\nExclusion Criteria:\n\n1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;\n2. History of allergy or hypersensitivity reactions.\n3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;\n4. History of blood donation or blood loss (\\>450mL) within 3 months prior to randomization;\n5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;\n6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;\n7. History of drug abuse, substance use;\n8. History of alcoholism or positive alcohol test results;\n\n11\\. History of long-term heavy smoking .",true,"MALE","18 Years","45 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.",[77],"Health Adult Subjects","NOT_YET_RECRUITING","2026-03-26",{"date":81,"type":82},"2026-04-01","ACTUAL",{"date":84,"type":71},"2026-04-30",{"date":86,"type":71},"2026-10-10",{"name":5,"class":6},1]