Healthy Volunteers
Conditions
Interventions
HLX04 Group:HLX04 supplied as 100 mg/4 mL solution
reconstituted to 100 mL with 0.9% sodium chloride
a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
US Avastin Group:US Avastin supplied as 100 mg/4 mL solution
EU Avastin Group:EU Avastin supplied as 100 mg/4 mL solution
CN Avastin Group:CN Avastin supplied as 100 mg/4 mL solution
Sponsors
None
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who are willing to comply with the contraception restrictions for this study; 2. Subjects who are able and willing to give written informed consent; 3. Subjects who are willing to comply with the study restrictions from screening until end of study; 4. Adult males aged 18 to 50 years inclusive and between 19 and 26 kg/m2 body mass index and body weight = 50 kg and = 80 kg; 5. Subjects who are non smokers or have not used tobacco or nicotine containing products for at least 3 months preceding screening and have less than 5 cigarettes per day smoking history. Subjects must agree to refrain from smoking during days of confinement at the study center; 6. Subjects negative for Hepatitis B surface antigen, Hepatitis C virus antibody, Treponema pallidum antibody, and human immunodeficiency virus antibody tests; 7. Subjects negative for urine drug screen and alcohol tests; 8. Subjects determined healthy by medical history, physical examination, laboratory tests, 12 lead electrocardiogram (ECG), and chest X ray, without any clinically significant abnormality judged by the Investigator.
Exclusion criteria
Exclusion criteria: Subjects will not be entered in the study for any of the following reasons: 1. History of gastrointestinal, endocrine, pulmonary, hepatic, renal, psychiatric, neurological, cardiovascular, hematological, and metabolic (including known diabetes mellitus) disease or disorder considered as significant by the Investigator; 2. History of any cancer, lymphoma, or leukemia, except basal cell carcinoma of skin after localized cancer is removed; 3. History or current clinically significant atopic allergy, hypersensitivity or allergic reactions including known or suspected clinically relevant drug hypersensitivity to any component of the study drug formulations or comparable drugs; 4. Any disorder that, in the Investigators opinion, may interfere with the safety of the subject and the study procedures and evaluations; 5. Blood loss or blood donation (including blood components donation) = 400 mL or blood transfusion within 3 months before screening; blood loss or blood donation (including blood components donation) = 200 mL within 1 months before screening; 6. Surgery within the past 8 weeks or surgery planned during the study duration; 7. Poor oral hygiene that may require surgical intervention during the study or any planned dental interventions during the study duration; 8. Live virus vaccination within 4 weeks prior to screening or intention to receive live virus vaccination during the study until the final follow up visit; 9. History of prior exposure to bevacizumab or any anti VEGF or anti VEGF receptor (VEGFR) monoclonal antibodies or proteins (e.g., aflibercept, ramucirumab, lapatinib, and sunitinib); 10. Prior exposure to any other investigational monoclonal antibody within 12 months of study drug administration; 11. Use of any investigational drug in any clinical study within the 3 months prior to first dose administration in this study; or remains on follow up of any clinical study; 12. Any intake of a non steroidal anti inflammatory drug (NSAID) including any dose of aspirin in the last 14 days. NSAIDs are not allowed for the duration of the study. Paracetamol is allowed for pain control if required; 13. Intake of prescribed or over the counter drugs within 28 days of study drug administration or herbal drugs or dietary supplements within 28 days prior to study drug administration; 14. Any persons who are: (1) An employee of the Principal Investigators, study centers, contract research organization (CRO) or the Sponsor; (2) A relative of an employee of the study centers, the Investigators, CRO or the Sponsor. 15. Abnormal ECG with clinical significance judged by the Investigator; 16. Abnormal serum Immunoglobulin G with clinical significance judged by the Investigator; 17. Confirmed positive ADA at screening; 18. Occurrence of acute disease during screening or predose, e.g., acute hepatitis, acute diarrhea; 19. Intake of any product containing alcohol within 24 hours of study drug administration; 20. Subjects with relevant family history of hypertension or abnormal blood pressure at screening or admission to the study center (Day 1): (1) Systolic blood pressure > 140 mmHg (2) Diastolic blood pressure > 90 mmHg. 21. Any inherited predisposition to bleeding or to thrombosis or history of non traumatic hemorrhage (i.e., requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count < 100000/µL) or an internati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs;ECG;hematology;serum chemistry;Coagulation indeces;urinalysis;Cmax;AUC(0-t);AUC(0-8);tmax;Immunogenicity; | — |
Countries
China
Contacts
Public ContactLu LUO
Shanghai Henlius Biotech Inc.
Outcome results
None listed