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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083990
Recruitment Status : Unknown
Verified March 2017 by Innovent Biologics (Suzhou) Co. Ltd..
Recruitment status was:  Recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Biological: IBI305(Bevacizumab) Drug: Avastin(Bevacizumab) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Group A
IBI 305 ,3mg/kg, infusion in 90 minutes
Biological: IBI305(Bevacizumab)
3mg/kg, infusion in 90minutes
Other Name: avastin

Active Comparator: Group B
Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes
Drug: Avastin(Bevacizumab)
3mg/kg, infusion in 90minutes
Other Name: avastin




Primary Outcome Measures :
  1. the area under the blood drug concentration - time curve form 0 to t (AUC0 - t) and time curve form 0 to ∞AUC0 - ∞) [ Time Frame: 99 days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)

  2. the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞) [ Time Frame: 99 days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 99 days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)

  2. elimination half life [ Time Frame: 99 days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)

  3. clearance rate [ Time Frame: days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)

  4. apparent volume of distribution [ Time Frame: 99 days ]
    before infusion(in 60 min),infusion over(in 5 min),infusion start 4 h(±10 min)、12 h(±20 min)、24 h(±1 h)、48 h(±1 h)、96 h(±1 h)、168 h(±8 h)、336 h(±12 h)、504 h(±24 h)、672 h(±24 h)、1008 h(±48 h)、1344 h(±48 h)、1512 h(±48 h)、1680 h(±48 h)and 2016 h(±48 h)

  5. vital signs [ Time Frame: 99 days after administration ]
    blood presure, temperature,pulse

  6. physical examination [ Time Frame: 99 days after administration ]
    general status

  7. lab test: [ Time Frame: 99 days after administration ]
    Hematology inspection, urinalysis, hematological biochemistry, hemostasis examination

  8. ECG [ Time Frame: 99 days after administration ]
    electrocardiogram

  9. Adverse Event [ Time Frame: 99 days after administration ]
    Adverse Event

  10. positive rate of ADA( anti-drug antibody) [ Time Frame: 99 days after administration ]
    ADA( anti-drug antibody)

  11. positive rate of NAb [ Time Frame: 99 days after administration ]
    NAb(netrolizing anti-body)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083990


Contacts
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Contact: Yanhua Ding, Doctor +86 0431 88782168 ext 0 dingyanhua2003@126.com

Locations
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China, Jilin
Jinin University First Hospital Recruiting
Changchun, Jilin, China
Contact: Yanhua Ding, Doctor    0431-88782168    dingyanhua2003@126.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: yanhua Ding, Doctor Jilin University First Hospital

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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03083990    
Other Study ID Numbers: CIBI305A201
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors