A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
Assessment of safety of HLX02 at different doses. 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 German).
Inclusion Criteria:

 1. Provide the singed informed consent form (ICF)

 2. 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)

 3. Aged ≥18 and ≤45 years

 4. Body mass index (BMI) ≥19 and ≤28 kg/m2

 5. Weight ≥50 and ≤80 kg

 6. Left ventricular ejection fraction (LVEF) falls within the normal range as measured by
 echocardiogram (ECHO) within 14 days prior to randomisation

 7. 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

 8. 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:

 1. Any history of clinically serious diseases such as hematological, renal, endocrine,
 pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
 oncologic, or allergic diseases

 2. Clinically significant abnormalities in laboratory test results

 3. Previous exposure to any monoclonal antibody or current use of any biologics

 4. History of allergic or anaphylactic reactions including those occurred during any
 clinical study or those caused by any drug or any of its excipients

 5. 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

 6. History of a blood donation within 3 months prior to the administration of IP

 7. Have participated in any other clinical study within 3 months prior to the
 administration of IP

 8. Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus
 (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies

 9. Have a history of drug abuse

 10. 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.