NSCLC
Conditions
Interventions
Group A:TAB008 Monoclonal Antibody Injection,1 mg/kg, intravenous injection, single dose
Group B:Avastin injection 1 mg/kg, intravenous injection, single dose
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Males aged 18 to 45 years; 2. Subjects determined healthy by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and chest X-ray; 3. Normal or abnormal laboratory test results without clinical significance judged by the Investigator; 4. Body mass index (BMI) 19 to 28 kg/m2 and body weight 50 kg to 75 kg; 5. Blood pressure at screening or admission to the study center (Day -1): Systolic blood pressure 90 mmHg to 140 mmHg, diastolic blood pressure = 90 mmHg; 6. Subjects who are willing to comply with the study restrictions from contraceptive requirement (refer to Section 4.3.3); 7. Subjects who are able and willing to give written informed consent and are compliant.
Exclusion criteria
Exclusion criteria: 1. With history of hematological, central neurological and psychiatric, cardiovascular, hepatic, renal, gastrointestinal, pulmonary, endocrine and metabolic (including known diabetes mellitus) disease or other important disorder considered as significant by the Investigator; 2. Current acute, chronic active infection or history of active tuberculosis; 3. Participated any other clinical study within 3 months before screening or use of any drug known have obvious damage to major organs within 3 months prior to first dose administration in this study; 4. Blood loss or blood donation > 200 mL in the 3 months before screening; 5. Normal or abnormal laboratory test results during screening or admission with clinical significance judged by the Investigator; 6. Confirmed positive bevacizumab ADA at screening; 7. 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 or an international normalized ratio (INR) higher than 1.44; 8. 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; Abnormal serum Immunoglobulin E with clinical significance judged by Investigator; 9. Abnormal ECG with clinical significance judged by the Investigator, or QTc > 450ms; 10. History of postural hypotension; 11. Vaccination within 12 weeks prior to screening or intention to receive vaccination during the study until the final follow up visit; 12. History of prior exposure to bevacizumab or any anti VEGF or anti VEGF receptor (VEGFR) monoclonal antibodies or proteins; 13. Received any biologic agent treatment within 3 months prior to study drug administration, or received any monoclonal antibodies treatment within 12 months prior to study drug administration; 14. Any major injury or surgery defined by the Investigator within the past 8 weeks, or any minor surgery within the past 4 weeks, or any surgery planned during the study duration (including possible need/planned surgery on dental problems); 15. Intake of any drugs within 14 days prior to study drug administration; 16. Over 5 pack-year smoking history, or used tobacco or nicotine containing products within 3 months before screening, or Subjects who are not willing to refrain from smoking during the study (refer to Section 4.3.3); 17. History of alcohol abuse (defined as more than 14 units of alcohol per week, 1 unit=285 mL beer=25 mL spirits=80 mL wine), or a positive alcohol breath test before study drug administration, or Subjects who are not willing to comply with the refrainment from alcohol for this study (refer to Section 4.3.3); 18. History of drug taking or drug abuse, or positive drug screening, or Subjects who are not willing to refrain from drug abuse for this study; 19. Subject spouses pregnancy planned within 190 days; 20. Subject inadequate communication, understand and cooperation, or poor compliance to protocol required follow-up visits; 21. Any other reason judged by the investigator not appropriate to participating the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse;Respiration;Blood Pressure;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;Cmax;AUC0-t;AUC0-8;Immunogenicity; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Outcome results
None listed