The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.
Male subjects aged ≥18 and ≤45 years;
The skin at the injection site is intact, without damage, tattoos, or other markings;
Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;
History of allergy or hypersensitivity reactions.
Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
Parallel
HLX319
DrugHLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
EU-Phesgo
DrugEU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
AUC0-inf
Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration
Cmax
Peak concentration after a single administration
AUC0-t
Area-under-curve of the blood drug concentration-time curve from time zero to the last quantifiable concentration time
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