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

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