Health Adult Subjects
Conditions
Brief summary
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.
Interventions
DRUGHLX319
HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
DRUGEU-Phesgo
EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects aged ≥18 and ≤45 years; 2. The skin at the injection site is intact, without damage, tattoos, or other markings; 3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial; 4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance. 5. Body weight (BW) ≥50 and ≤75 kg; 6. Body mass index (BMI) ≥19 and ≤24 kg/m² \[BMI = weight (kg) / height² (m²)\]; 7. 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 upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization; 7. History of drug abuse, substance use; 8. History of alcoholism or positive alcohol test results; 11\. History of long-term heavy smoking .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf | up to 85 days | Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration |
| Cmax | up to 85 days | Peak concentration after a single administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | up to 85 days | Area-under-curve of the blood drug concentration-time curve from time zero to the last quantifiable concentration time |
Countries
China
Contacts
CONTACTqi Jin
Outcome results
None listed