Pharmacokinetics and Safety Study of ASKB1202 in Chinese Healthy Subjects

NCT03115762 | Unknown Phase 1

• 1 other identifier: ASK-LC-B1202-1
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

ASKB1202

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Tmax

  up to 100 days

• t1/2

  up to 100 days

Study Arms (3)

ASKB1202

EXPERIMENTAL

Subject to receive one intravenous (i.v.) infusion of ASKB1202

Biological: ASKB1202

bevacizumab A

ACTIVE COMPARATOR

Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in China

Biological: bevacizumab

bevacizumab B

ACTIVE COMPARATOR

Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in Europe

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells

bevacizumab A; bevacizumab B

ASKB1202 BIOLOGICAL

ASKB1202

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Clinical laboratory tests is normal or the abnormality is not clinical significant determined by researchers.
• The subjects were willing to take effective contraceptive measures within 2 months before use of the drug and 6 months after.
• 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.

You may not qualify if:

• Any evidence of a historical or existing clinically relevant concomitant disease, as determined by researchers.
• Acute,chronic active infections during screening of the study and admission(1 day before treatment),or has a history of active tuberculosis.
• 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 .
• Any finding of abnormality which has clinical significance during the screening of the clinical tests determined by researchers.
• 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.
• 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.
• 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.
• Abnormal electrocardiogram (ECG) with clinical significance, such as QTc interphase is greater than 450 milliseconds.
• 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.
• Suffered from malignant tumors (except that controlled basal cell carcinoma and squamous cell carcinoma).
• Has been vaccinated within 4 weeks before screening , or plan to get the vaccine during the study period.
• Has a history of taking beacizumab or anti VEGF targeted agents or having the antibody of anti VEGF.
• Participated in another trial within three months prior to administration or had a monoclonal antibody therapy within twelve months prior to administration.
• 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.
• Used any drug that is harmful to major organs within 3 months before administration,or use any drug within 14 days prior to participation.

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 14, 2017
• Study Start: June 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04