A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).

Official Title
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A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HLX02
* Drug: EU-sourced Trastuzumab (Herceptin®)
* Drug: US-licensed Trastuzumab (Herceptin®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed Informed Consent Form Healthy Chinese male (healthy is defined as the fact that no clinically significant abnormalities are identified by medical history, physical examination, vital signs, chest X ray, 12-lead ECG and laboratory tests) Aged ≥ 18 and ≤ 45 years Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2 Body weight ≥ 50 and ≤ 80 kg LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (>50%) Immunogenicity (anti-drug [anti-trastuzumab] antibody [ADA]) tested as negative Subject agrees that he and his female spouse/partner use reliable contraceptive methods from the time of administration of study drug until 3 months after the end of study, or subject is infertile Exclusion Criteria: Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study Use of any prescription or non-prescription drug or dietary supplement within 5 half lives of such drug or dietary supplement or 2 weeks prior to the administration of the study drug (whichever is longer). The traditional Chinese medicine-based dietary supplement should be discontinued 28 days prior to administration of the study drug Donation of blood within 3 months prior to the administration of the study drug Participation in other clinical studies within 3 months prior to the administration of the study drug Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum History of drug abuse Inability to follow the protocol requirements, instructions and study limitations as judged by investigators, such as noncooperation, inability to return to the site for follow-up visits or inability to complete the whole clinical study Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX02<br>patient receive one dose of HLX02 | Drug: HLX02<br>* subject receive one dose of HLX02<br>|
| Active Comparator: EU-sourced Trastuzumab (Herceptin®)<br>patient receive one dose of EU-sourced Trastuzumab (Herceptin®) | Drug: EU-sourced Trastuzumab (Herceptin®)<br>* subject receive one dose of EU-sourced Trastuzumab (Herceptin®)<br>|
| Active Comparator: US-licensed Trastuzumab (Herceptin®)<br>patient receive one dose of US-licensed Trastuzumab (Herceptin®) | Drug: US-licensed Trastuzumab (Herceptin®)<br>* subject receive one dose of US-licensed Trastuzumab (Herceptin®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time zero to infinity (AUCinf) |  | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) |  | 57 days | 
| time to Cmax (Tmax) |  | 57 days |