[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652733":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HLX29","EXPERIMENTAL","subjects will receive a single intravenous dose of HLX29",[13],"Drug: HLX29",{"label":15,"type":16,"description":17,"interventionNames":18},"HLX11","ACTIVE_COMPARATOR","subjects will receive a single intravenous dose of HLX11",[19],"Drug: HLX11",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pertuzumab injection after process change",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Pertuzumab injection before process change",[15],[30],{"name":31,"affiliation":32,"role":33},"Wei HU, Dr","Anhui Medical University Second Affiliated Hospital","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"changan Fang","CONTACT","8617742005405","Chengan_Fang@henlius.com",[41],{"facility":32,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hefei","Anhui","230601","China","CN",{"type":48,"coordinates":49},"Point",[50,51],117.28083,31.86389,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Wei Hu, Dr","86-0551-65997164","hwgcp@ayefy.com",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100652733","phase-1-pharmacokinetic-characteristics-safety-and-immunogenicity-of-hlx29-compared-with-hlx11-100652733",false,"NCT07776132","Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11","A RANDOMIZED, DOUBLE-BLIND, INTRAVENOUS SINGLE-DOSE, PARALLEL-CONTROLLED PHASE I CLINICAL STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND IMMUNOGENICITY OF PERTUZUMAB INJECTION BEFORE AND AFTER PROCESS CHANGE IN HEALTHY CHINESE MALE PARTICIPANTS","Inclusion Criteria:\n\n1. Male subjects aged ≥18 and ≤45 years;\n2. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;\n3. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.\n4. Body mass index (BMI) ≥19 and ≤26 kg\u002Fm²;\n5. 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 drug abuse, substance use;\n7. History of alcoholism or positive alcohol test results;\n8. History of long-term heavy smoking .",true,"MALE","18 Years","45 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.",[79],"Health Adult Subjects","NOT_YET_RECRUITING","2026-08-17",{"date":83,"type":84},"2026-08-20","ACTUAL",{"date":86,"type":73},"2026-09-05",{"date":88,"type":73},"2027-02-01",{"name":5,"class":6},1]