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

NCT ID: NCT03083990

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2017-08-17

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

IBI305(Bevacizumab Biosimilar)

Intervention Type: BIOLOGICAL

3mg/kg, infusion in 90minutes

Group B

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

Group Type: ACTIVE_COMPARATOR

Avastin(Bevacizumab)

Intervention Type: DRUG

3mg/kg, infusion in 90minutes

Interventions

IBI305(Bevacizumab Biosimilar)

3mg/kg, infusion in 90minutes

Intervention Type: BIOLOGICAL

Avastin(Bevacizumab)

3mg/kg, infusion in 90minutes

Intervention Type: DRUG

Other Intervention Names

avastin

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jilin University First Hospital

Locations

Jilin University First Hospital

Changchun, Jilin, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIBI305A201

Identifier Type: -

Identifier Source: org_study_id