Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
Condition: Healthy
Intervention: IBI305(Bevacizumab Biosimilar); Avastin(Bevacizumab)
Intervention description: 3mg/kg, infusion in 90minutes; 3mg/kg, infusion in 90minutes
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
    

Eligibility criteria:

        Inclusion Criteria:

          -  To be eligible for the study, patients should fulfill all the following criteria:

               1. Fully understand the study purpose, and understand the pharmacological effects
                  and potential adverse reactions of the drug, voluntarily signed written informed
                  consent according to the declaration of Helsinki.

               2. Age ≥18 and ≤ 50, healthy male subjects

               3. Weigh ≥ 50 kg and ≤ 100 kg， BMI≥ 19 and ≤ 28 kg/m2

               4. All the system test result within the normal range, or abnormal test results
                  without clinical significance judged by the investigator.

               5. The subjects must agree to use effective contraceptive measures during the study
                  treatment and for 6 months after receiving last does of study drug (e.g.
                  abstinence, sterilization surgery, oral contraceptives, contraception by
                  progesterone injection or subcutaneous)

        Exclusion Criteria:

          -  Patients should not enter the study if any of the following exclusion criteria are
             fulfilled:

               1. Medical history of high blood pressure or abnormal blood pressure at
                  screening/baseline(Double confirmed systolic blood pressure (SBP) >140 mmHg
                  and/or diastolic blood pressure (DBP) > 90 mmHg within one day)

               2. Proteinuria with clinical significance judged by the investigator (routine urine
                  examination, urine protein 2 + and above) or a history of proteinuria.

               3. Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial
                  Growth Factor Receptor) antibody or protein treatment within one year.

               4. Any biological products or a live virus vaccine treatment within 3 months , or
                  any monoclonal antibodies within 12 months before the first dose of study drug.

               5. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus.

               6. History of digestive tract perforation or digestive tract fistula.

               7. Serious, non-healing wound, active ulcer, or untreated bone fracture, or major
                  surgical procedure within 2 months prior to randomization or anticipation of need
                  for major surgery during the course of the study or 2 months after last dose of
                  the study drug.

               8. Use Rx or OTC drugs or nutritional health products within 5 half-lives or within
                  2 weeks before the first dose of study drug (According to the longer time).Herbal
                  supplements need to stop at 28 days before the first dose of study drug.

               9. Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody,
                  or human immunodeficiency virus (HIV) antibody or syphilis

              10. Known hypersensitivity to Bevacizumab or any excipients

              11. Known allergic disease or allergic constitution

              12. History of blood donation within 3 months before the first dose of study drug

              13. Treatment with any other investigational agent or participation in another
                  clinical trial within 3 months prior to screening

              14. History of alcoholism or drug abuse within 12 months prior to screening; Subjects
                  cannot temperance within 72 hours before study drug infusion and during the whole
                  study

              15. History of mental illness

              16. Anticipated of partner pregnancy during the study.

              17. Incompliance to the clinical study protocol during the study.

              18. Other conditions that the investigator thinks unsuitable in this study