Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.

Official Title
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A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: HLX11
* Drug: CN-Perjeta(Pertuzumab)
* Drug: EU-Perjeta(Pertuzumab)
* Drug: US-Perjeta(Pertuzumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Chinese males aged ≥ 18 and ≤ 45 body mass index (BMI) ≥ 19 and ≤ 26 kg/m2 LVEF≥ 55% Exclusion Criteria: A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases Use of a monoclonal antibody or any biological product within 6 months before study drug administration A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration A history of blood donation within 3 months before study drug administration Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody A history of drug abuse Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX11 group<br>HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). | Drug: HLX11<br>* healthy volunteers receive HLX11 (420mg) once<br>|
| Active Comparator: CN-Perjeta group<br>CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). | Drug: CN-Perjeta(Pertuzumab)<br>* healthy volunteers receive CN-Perjeta (420mg) once<br>|
| Active Comparator: EU-Perjeta group<br>EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). | Drug: EU-Perjeta(Pertuzumab)<br>* healthy volunteers receive EU-Perjeta (420mg) once<br>|
| Active Comparator: US-Perjeta group<br>US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min). | Drug: US-Perjeta(Pertuzumab)<br>* healthy volunteers receive US-Perjeta (420mg) once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak concentration | from predose to 2352 hours (Day 99),13 timepoints | 
| AUC0 t | Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point | from predose to 2352 hours (Day 99),13 timepoints | 
| AUC0 inf | Area under the plasma concentration-time curve from time 0 to infinity | from predose to 2352 hours (Day 99),13 timepoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of 4 groups | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | from day1 to day 99 | 
| safety and tolerability of 4 groups | Number of AE as assessed by CTCAE v5.0 | from day1 to day 99 | 
| safety and tolerability of two groups | AE listing as assessed by CTCAE v5.0 | from day1 to day 99 |