[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659104":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":35,"overallOfficials":13,"centralContacts":43,"locations":13,"responsibleParty":54,"collaborators":13,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":13,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":13,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":13},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"AUC0-∞","Area under the serum concentration-time curve from time 0 to infinity","up to 99 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR","This is a randomized, double-blind, single-dose, parallel-controlled clinical trial to compare the PK profile of QL1209 and Perjeta® in healthy male participants. It is planned to enroll 80 healthy male participants and randomize them into the test group or reference group at a ratio of 1:1.\n\nParticipants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on Day 1, followed by observation until Day 99 post-dose for PK, safety and immunogenicity assessments.\n\nThe study will include a screening period from Day 28 to Day 1. The participants will be admitted to the clinical study site on Day 1 and receive the QL1209 or US-Perjeta® on Day 1. The participants will remain in the in-patient department for observation until the assessment on Day 3 is completed. Participants will return to the clinical study site for out-patient visits till Day 99 or upon early withdrawal.\n\nIn the study, validated test methods will be used to determine QL1209\u002FPertuzumab concentrations in PK samples at different visit points after infusion administration. Non- compartmental models will be used to calculate PK parameters and perform statistical analysis. Anti-drug antibody (ADA) and titer in immunogenicity samples will be determined using a validated test method, and neutralizing antibody (Nab) will be further tested for ADA-positive samples.",[25,30],{"label":26,"type":27,"description":13,"interventionNames":28},"QL1209","EXPERIMENTAL",[29],"Drug: QL1209",{"label":31,"type":32,"description":13,"interventionNames":33},"US-Perjeta®","ACTIVE_COMPARATOR",[34],"Drug: US-Perjeta®",[36,40],{"type":37,"name":26,"description":38,"armGroupLabels":39,"otherNames":13},"DRUG","A single intravenous infusion of QL1209 420 mg for 60 min ± 10 min.",[26],{"type":37,"name":31,"description":41,"armGroupLabels":42,"otherNames":13},"A single intravenous infusion of US-Perjeta® 420 mg for 60 min ± 10 min.",[31],[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Anne Monroe, MD","CONTACT","240-673-0500","1716","anne.monroe@pharmaron-us.com",{"name":51,"role":46,"phone":47,"phoneExt":52,"email":53},"James Phillips, MHCI","1750","James.Phillips@pharmaron-us.com",{"type":55,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659104","phase-1-comparative-study-of-ql1209-and-perjeta-in-healthy-male-participants-100659104",false,"NCT07861139","Comparative Study of QL1209 and Perjeta® in Healthy Male Participants","A Randomized, Double-Blind, Single-Dose, Parallel-Controlled Clinical Study to Compare the Pharmacokinetic Similarity Between QL1209 (Perjeta® Biosimilar Candidate) and Perjeta® (Pertuzumab) in Healthy Male Participants","Inclusion Criteria:\n\n1. Healthy male participants aged 18-55 (inclusive);\n2. Participants with body weight of ≥50 kg (inclusive)) and body mass index (BMI) of 18.5-32.0 kg\u002Fm2 (inclusive);\n3. Participants who voluntarily sign the written ICF;\n4. Participants who are able to communicate well with the investigator and complete the study as per the study protocol;\n5. Male participants who agree to use reliable contraceptives (such as abstinence, contraceptive barrier, sterilization surgery) for themselves and their partners (such as birth control pills, contraceptive barrier, injection of the contraceptive medroxyprogesterone acetate or contraception by subcutaneous implantation), and agree not to donate sperm, during the study and within 7 months after infusion of the investigational product.\n\nExclusion Criteria:\n\n1. Trial participants with a history of or currently having any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematological, immunological, psychiatric and metabolic disorders, or any other diseases that may interfere with the study results, or participants with clinically significant allergic reactions or allergic constitution, angioedema, interstitial pneumonitis or acute respiratory distress syndrome;\n2. Participants with abnormal vital signs (systolic blood pressure \\\u003C 90 mmHg or \\> 140 mmHg, diastolic blood pressure \\\u003C 50 mmHg or \\> 90 mmHg; heart rate \\\u003C 50 bpm or \\> 100 bpm) or clinically significant abnormalities in physical examination, ECG and laboratory tests (participant to the judgment of clinicians), and those whose LVEF is beyond the normal range as shown by echocardiography; Adult males with a left ventricular ejection fraction (LVEF) outside the normal reference range of 52% to 72%, as defined by the American Society of Echocardiography (ASE), will be excluded;\n3. Any clinically relevant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; including alanine aminotransferase (ALT) \\>1.1 × upper limit of normal (ULN), aspartate aminotransferase (AST) \\>1.2 × ULN, bilirubin (total) \\>1.5 × ULN. Participants with estimated glomerular filtration rate (eGFR) based on Cockcroft-Gault equation \\\u003C 90 mL\u002Fmin\u002F1.73 m2 will be excluded. If any of these tests are out-of-range, the tests can be repeated once;\n4. QT interval corrected for heart rate using Fridericia's correction (QTcF) \\> 450 msec.\n5. Participants with poor venous access;\n6. Participants with a history of allergy to the investigational product (pertuzumab or any of its excipients), or, significant allergy to food, or other substances;\n7. Participants treated with anti-HER2 therapy or any antibody or other protein drug targeting the HER2 receptor;\n8. Participants who have taken any prescription or OTC drugs, including any herbal, and\u002For nutritional supplements (e.g. vitamins, mineral supplements or other health products) within 14 days before screening;\n9. Use of any monoclonal antibody within 3 months or 5 half-lives (whichever is longer) before administration;\n10. Use of investigational drugs within 30 days or 5 half-lives (whichever is longer) or discontinuation of monoclonal antibodies with unknown half-life within 6 months; prior to scheduled administration of the investigational drugs on Day 1 of this study.",true,"MALE","18 Years","55 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male participants.\n\nParticipants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on D1, followed by observation until Day 99 postdose for PK, safety and immunogenicity assessments.",[75],"Breast Cancer",[77,78,79],"Comparative Pharmacokinetic","QL2109","Perjeta","NOT_YET_RECRUITING","2026-10-08",{"date":83,"type":84},"2026-10-09","ACTUAL",{"date":86,"type":69},"2026-10",{"date":88,"type":69},"2027-09",{"name":5,"class":6}]