Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

A RANDOMIZED, DOUBLE-BLIND, INTRAVENOUS SINGLE-DOSE, PARALLEL-CONTROLLED PHASE I CLINICAL STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND IMMUNOGENICITY OF PERTUZUMAB INJECTION BEFORE AND AFTER PROCESS CHANGE IN HEALTHY CHINESE MALE PARTICIPANTS

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.

Inclusion Criteria:

1. Male subjects aged ≥18 and ≤45 years;
2. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
3. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
4. Body mass index (BMI) ≥19 and ≤26 kg/m²;
5. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);

Exclusion Criteria:

1. 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;
2. History of allergy or hypersensitivity reactions.
3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
4. History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;
6. History of drug abuse, substance use;
7. History of alcoholism or positive alcohol test results;
8. History of long-term heavy smoking .