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

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ClinicalTrials.gov Identifier: NCT03083990
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : November 4, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information
First Submitted Date  ICMJE November 12, 2016
First Posted Date  ICMJE March 20, 2017
Results First Submitted Date  ICMJE July 6, 2020
Results First Posted Date  ICMJE November 4, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date August 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • AUC0 - t [ Time Frame: 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 ]
    the area under the blood drug concentration time curve form 0 to t (AUC0 - t)
  • AUC0 - ∞ [ Time Frame: 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 ]
    the area under the blood drug concentration time curve form 0 to ∞AUC0 - ∞)
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
  • 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)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Cmax [ Time Frame: 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 ]
    Maximum serum concentration
  • t1/2 [ Time Frame: 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 ]
    elimination half life
  • Clearance Rate [ Time Frame: 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 clearance
  • Apparent Volume of Distribution [ Time Frame: 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(V)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
  • 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)
  • 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)
  • 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)
  • 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)
  • vital signs [ Time Frame: 99 days after administration ]
    blood presure, temperature,pulse
  • physical examination [ Time Frame: 99 days after administration ]
    general status
  • lab test: [ Time Frame: 99 days after administration ]
    Hematology inspection, urinalysis, hematological biochemistry, hemostasis examination
  • ECG [ Time Frame: 99 days after administration ]
    electrocardiogram
  • Adverse Event [ Time Frame: 99 days after administration ]
    Adverse Event
  • positive rate of ADA( anti-drug antibody) [ Time Frame: 99 days after administration ]
    ADA( anti-drug antibody)
  • positive rate of NAb [ Time Frame: 99 days after administration ]
    NAb(netrolizing anti-body)
Current Other Pre-specified Outcome Measures
 (submitted: November 12, 2020)
  • Number of Participants Positive for Nab(Neutralizing Antibody) [ Time Frame: 99 days after administration ]
    The analysis of NAb was done by Covance Pharmaceutical R&D (Shanghai) Co., Ltd. using methodologically validated ECL immunoassay.
  • Number of Participants Positive for Anti-drug Antibodies [ Time Frame: 99 days after administration ]
    The analysis of ADA was done by Wuxi AppTec (Shanghai) Co., Ltd. using methodologically validated electrochemiluminescence (ECL) immunoassay.
  • Systolic Blood Pressure [ Time Frame: 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 ]
    Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
  • Diastolic Blood Pressure [ Time Frame: 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 ]
    Systolic blood pressure and diastolic blood pressure on certain timepoints are measured and recorded.
  • Urinalysis [ Time Frame: Baseline,D2,D5,D15,D29,D57,D71,D99 ]
    Urine specific gravity as assessed by laboratory tests up to 99 days post-treatment
  • Hemoglobin [ Time Frame: Baseline,D2,D5,D15,D29,D57,D71,D99 ]
    Hemoglobin as assessed by laboratory tests up to 99 days post-treatment.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
Official Title  ICMJE 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
Brief Summary To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: IBI305(Bevacizumab Biosimilar)
    3mg/kg, infusion in 90minutes
  • Drug: Avastin(Bevacizumab)
    3mg/kg, infusion in 90minutes
    Other Name: avastin
Study Arms  ICMJE
  • Experimental: Group A
    IBI 305 ,3mg/kg, infusion in 90 minutes
    Intervention: Biological: IBI305(Bevacizumab Biosimilar)
  • Active Comparator: Group B
    Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes
    Intervention: Drug: Avastin(Bevacizumab)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 17, 2017
Actual Primary Completion Date August 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03083990
Other Study ID Numbers  ICMJE CIBI305A201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovent Biologics (Suzhou) Co. Ltd.
Study Sponsor  ICMJE Innovent Biologics (Suzhou) Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: yanhua Ding, Doctor Jilin University First Hospital
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP