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Pharmacokinetics and Safety Study of ASKB1202 in Chinese Healthy Subjects

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. Identifier: NCT03115762
Recruitment Status : Unknown
Verified April 2017 by Jiangsu Aosaikang Pharmaceutical Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Brief Summary:
This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of ASKB1202 compared to bevacizumab sold in China and Europe.

Condition or disease Intervention/treatment Phase
Healthy Biological: bevacizumab Biological: ASKB1202 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetics,Safety and Immunogenicity of ASKB1202 in Chinese Healthy Subjects: a Randomized, Double-blinded, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: ASKB1202
Subject to receive one intravenous (i.v.) infusion of ASKB1202
Biological: ASKB1202
Active Comparator: bevacizumab A
Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in China
Biological: bevacizumab
recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells

Active Comparator: bevacizumab B
Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in Europe
Biological: bevacizumab
recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells

Primary Outcome Measures :
  1. Cmax [ Time Frame: up to 100 days ]
    Maximum measured concentration of the analyte in plasma

  2. AUC0-t [ Time Frame: up to 100 days ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point

  3. AUC0-∞ [ Time Frame: up to 100 days ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Secondary Outcome Measures :
  1. Tmax [ Time Frame: up to 100 days ]
    Time to peak

  2. t1/2 [ Time Frame: up to 100 days ]
    Terminal-phase elimination half-life

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 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 1.Healthy males,aged 18 to 50 years. 2.A complete medical history, including disease history,physical examination, vital signs, 12-lead electrocardiogram (ECG), and chest X-ray image.

    3.Clinical laboratory tests is normal or the abnormality is not clinical significant determined by researchers.

    4.The subjects were willing to take effective contraceptive measures within 2 months before use of the drug and 6 months after.

    5.The subjects could understand the procedures and methods of this study, were willing to strictly abide the clinical trial plan to complete the test, sign the Informed Notice.

Exclusion Criteria:

  • 1.Any evidence of a historical or existing clinically relevant concomitant disease, as determined by researchers.

    2.Acute,chronic active infections during screening of the study and admission(1 day before treatment),or has a history of active tuberculosis.

    3.Hemorrhaged or donated blood (including the components of blood donation), or received blood transfusion ≥400 mL within 3 months before screening;Hemorrhaged or donated blood (including the components of blood donation) ≥200 mL within a month before the screening .

    4.Any finding of abnormality which has clinical significance during the screening of the clinical tests determined by researchers.

    5.Currently suffering from hypertension,abnormal blood pressure during study screening and hospital admission(1 day before use of drug):systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.

    6.Any disease causes it to increase the risk of bleeding or thrombosis, such as bleeding or thrombosis genetic predisposition, or has a history of traumatic hemorrhage, thromboembolic events, blood coagulation disease and thrombocytopenia (platelet count <100000/L) or international standardization ratio (INR) is higher than 1.44.

    7.Suffered or suffering from clinical significant atopic allergy, hypersensitivity or allergic reaction, including known or suspected sensitive to one component in drug; abnormal serum immunoglobulin E (IgE) determined by researchers.

    8.Abnormal electrocardiogram (ECG) with clinical significance, such as QTc interphase is greater than 450 milliseconds.

    9.A history of gastrointestinal perforation or any fistula. 10.Has a wound without healing or fracture in study screening and admission. 11.Orthostatic hypotension, syncope and dizziness or has a history of shock caused by any reason.

    12.Suffered from malignant tumors (except that controlled basal cell carcinoma and squamous cell carcinoma).

    13.Has been vaccinated within 4 weeks before screening , or plan to get the vaccine during the study period.

    14.Has a history of taking beacizumab or anti VEGF targeted agents or having the antibody of anti VEGF.

    15.Participated in another trial within three months prior to administration or had a monoclonal antibody therapy within twelve months prior to administration.

    16.Received a surgery within 28 days prior to administration, including dental suture or wound dehiscence, or plan to undergo surgery including dental surgery during the study and 60 days after the last administration of the protocol specified treatment.

    17.Used any drug that is harmful to major organs within 3 months before administration,or use any drug within 14 days prior to participation.

    18.Smoker who smoked >5 cigarettes per day within 3 months prior to the research and unable to refrain from smoking during the research.

    19.History of alcohol abuse(drink alcohol more than 14 units a week [1 unit = 285 mL beer or 25 mL of liquor or 100 mL of wine); positive result for alcohol breath test within 24h before treatment;or unable to refrain from drinking during the study.

    20.History of taking drugs or drug abuse;or positived result for drug screening;or unable to refrain from drug abuse during the study.

    21.Positive hepatitis b surface antigen , hepatitis c antibody , HIV antibody and syphilis antibody.

    22.Any condition that not suitable to anticipate the research or bring obvious risks to the subjects according to researchers.

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Responsible Party: Jiangsu Aosaikang Pharmaceutical Co., Ltd. Identifier: NCT03115762    
Other Study ID Numbers: ASK-LC-B1202-1
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Aosaikang Pharmaceutical Co., Ltd.:
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors