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

Study Overview
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Brief Summary
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To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .

Official Title
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Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Conditions
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Healthy

Intervention / Treatment
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* Biological: IBI305(Bevacizumab Biosimilar)
* Drug: Avastin(Bevacizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the study, patients should fulfill all the following criteria: 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. Age ≥18 and ≤ 50, healthy male subjects Weigh ≥ 50 kg and ≤ 100 kg， BMI≥ 19 and ≤ 28 kg/m2 All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator. 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: 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) Proteinuria with clinical significance judged by the investigator (routine urine examination, urine protein 2 + and above) or a history of proteinuria. Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year. 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. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus. History of digestive tract perforation or digestive tract fistula. 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. 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. Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis Known hypersensitivity to Bevacizumab or any excipients Known allergic disease or allergic constitution History of blood donation within 3 months before the first dose of study drug Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening 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 History of mental illness Anticipated of partner pregnancy during the study. Incompliance to the clinical study protocol during the study. Other conditions that the investigator thinks unsuitable in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>IBI 305 ,3mg/kg, infusion in 90 minutes | Biological: IBI305(Bevacizumab Biosimilar)<br>* 3mg/kg, infusion in 90minutes<br>|
| Active Comparator: Group B<br>Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes | Drug: Avastin(Bevacizumab)<br>* 3mg/kg, infusion in 90minutes<br>* Other names: avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0 - t | the area under the blood drug concentration time curve form 0 to t (AUC0 - t) | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days | 
| AUC0 - ∞ | the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞) | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum serum concentration | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days | 
| t1/2 | elimination half life | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days | 
| Clearance Rate | apparent clearance | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days | 
| Apparent Volume of Distribution | apparent volume of distribution(V） | 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days |