A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

Inclusion criteria

• Provide the singed informed consent form (ICF)
• Healthy Chinese male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests)
• Aged ≥18 and ≤45 years
• Body mass index (BMI) ≥19 and ≤28 kg/m2
• Weight ≥50 and ≤80 kg
• Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation
• Subjects must agree that they and their female spouse/partners will use reliable contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential from the time of the administration of investigational product (IP) until the completion of the study
• Do not smoke or smoke fewer than 5 cigarettes daily within three months prior to screening; do not drink or drink less than 14 units of alcohol within six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine)

Exclusion criteria

• Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases
• Clinically significant abnormalities in laboratory test results
• Previous exposure to any monoclonal antibody or current use of any biologics
• History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients
• Use of prescription or non prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking IP (whichever is longer). Herbal supplements must be discontinued 28 days prior to the IP
• History of a blood donation within 3 months prior to the administration of IP
• Have participated in any other clinical study within 3 months prior to the administration of IP
• Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies
• Have a history of drug abuse
• Unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits or improbability of completing the whole clinical study, etc.