Clinical Trial in Chinese Healthy Volunteers of GB222

NCT ID: NCT04175158

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2020-11-30

Brief Summary

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GB222

1mg/kg

Group Type: EXPERIMENTAL

GB222

Intervention Type: BIOLOGICAL

Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.

Bevacizumab

1mg/kg

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: BIOLOGICAL

Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.

Interventions

GB222

Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.

Intervention Type: BIOLOGICAL

Bevacizumab

Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.

Intervention Type: BIOLOGICAL

Other Intervention Names

Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection; Avastin

Eligibility Criteria

Exclusion Criteria

1. Allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have abnormal serum immunoglobulin E (IgE);

2. Any current signs and symptoms or abnormalities in laboratory tests may indicate acute or subacute infection (fever, cough, urination, pain, abdominal pain, diarrhea, skin infection, wound, etc.)

3. History of drug addiction or drug abuse; subjects with positive urine drug screening;

4. Clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or other significant diseases; medical history of hypertension or screening systolic blood pressure³ of 140mmHg and/or diastolic blood pressure³ of 90mmHg,which are clinically significant at the discretion of the investigators;

5. People with malignant tumors;

6. Participated in other clinical studies within 3 months before enrollment, or subjects who received drugs which are known to injure the major organs within 3 months before enrollment;

7. Blood donation within 3 months before enrollment;

8. Surgery operation within 3 months before enrollment;

9. Use of prescription drugs or non-prescription drugs within 14 days before enrollment;

10. ALT or AST>1.5 ULN, Cr>ULN;

11. Hematology test: WBC<3.0×10 9 /L or > 9.5×10 9 /L; ANC < 1.5×10 9 /L; PLT<100×10 9/L; HGB<104 g/L,conform to any of these items;

12. Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);

13. Subjects who have positive anti-drug antibody (ADA);

14. Positive tumor marker (CEA、AFP、PSA、CA-125);

15. Abnormal coagulation function, which is judged by the researcher to be clinically significant;

16. Patients with a previous history of digestive tract ulcer, cerebrovascular accident, vascular lesions, etc., currently have open wounds of skin and mucosa. The researchers considered that other volunteers with risk of bleeding or coagulation should not be included in the study

17. Patients with a history of mental illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genor Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Fang, Master

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shawn Yu, Master

Role: CONTACT

shawn.yu@genorbio.com

18600332657

Facility Contacts

Yi Fang, Master

Role: primary

fygk7000@163.com

010-66583834

Other Identifiers

GENOR GB222-001; V1.3

Identifier Type: -

Identifier Source: org_study_id