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Completed

NCT Number: NCT03083990

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jilin University First Hospital

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBI305(Bevacizumab Biosimilar)

Biological

3mg/kg, infusion in 90minutes

Avastin(Bevacizumab)

Drug

3mg/kg, infusion in 90minutes

Other names: avastin

Primary outcomes

  1. 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)

  2. 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 - ∞)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Hemoglobin

    Time frame: Baseline,D2,D5,D15,D29,D57,D71,D99

    Hemoglobin as assessed by laboratory tests up to 99 days post-treatment.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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