Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: IBI305(Bevacizumab Biosimilar); Drug: Avastin(Bevacizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03083990

CIBI305A201

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group A

Experimental group

Description:

IBI 305 ,3mg/kg, infusion in 90 minutes

Treatment:

Biological: IBI305(Bevacizumab Biosimilar)

Group B

Active Comparator group

Description:

Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Treatment:

Drug: Avastin(Bevacizumab)