Health Adult Subjects
Conditions
Brief summary
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.
Interventions
DRUGHLX29
Pertuzumab injection after process change
DRUGHLX11
Pertuzumab injection before process change
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. 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf | up to 71 days | Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 71 days | Peak concentration after a single administration |
| AUC0-t | up to 71 days | Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration |
Countries
China
Contacts
CONTACTchangan Fang
STUDY_CHAIRWei HU, Dr
Anhui Medical University Second Affiliated Hospital
Outcome results
None listed