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

NCT03083990 | Completed Phase 1 Results

• 1 other identifier: CIBI305A201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Cmax

  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

  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

  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

  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

Other Outcomes (6)

• Number of Participants Positive for Nab（Neutralizing Antibody）

  99 days after administration

• Number of Participants Positive for Anti-drug Antibodies

  99 days after administration

• Systolic Blood Pressure

  0, D1( immediately after the end of infusion), D1 (4 hrs after the start of infusion), D1, 8 hrs after the start of infusion, D1 (12 hrs after the start of infusion), D2, D3, D5, D8, D15, D22, D29, D43, D57, D64, D71, D85, D99

Study Arms (2)

Group A

EXPERIMENTAL

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

Biological: IBI305(Bevacizumab Biosimilar)

Group B

ACTIVE COMPARATOR

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

Drug: Avastin(Bevacizumab)

Interventions

IBI305(Bevacizumab Biosimilar) BIOLOGICAL

3mg/kg, infusion in 90minutes

Group A

Avastin(Bevacizumab) DRUG

3mg/kg, infusion in 90minutes

Also known as: avastin

Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Jilin University First Hospital

Changchun, Jilin, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Yi Bo
• Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)

jessica.yi@innoventbio.com

+86 13382419112

Study Officials

• yanhua Ding, Doctor

  Jilin University First Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2016
• First Posted: March 20, 2017
• Study Start: March 9, 2017
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: November 27, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)