This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.
Male subjects aged ≥18 and ≤55 years;
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.
Body mass index (BMI) ≥18 and ≤30 kg/m²;
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
HLX29
DrugPertuzumab injection after process change
HLX11
DrugPertuzumab injection before process change
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 the serum concentration-time curve from time 0 to the time of the last quantifiable concentration
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