Pharmacokinetics and Safety Study of ASKB1202 in Chinese Healthy Subjects

Pharmacokinetics,Safety and Immunogenicity of ASKB1202 in Chinese Healthy Subjects: a Randomized, Double-blinded, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Biological: ASKB1202; Biological: bevacizumab

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum measured concentration of the analyte in plasma	up to 100 days
AUC0-t	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	up to 100 days
AUC0-∞	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	up to 100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to peak	up to 100 days
t1/2	Terminal-phase elimination half-life	up to 100 days

Collaborators and Investigators

• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ASKB1202
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ASK-LC-B1202-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No