Clinical Trial in Chinese Healthy Volunteers of GB222

A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.

Sponsors

Lead Sponsor: Genor Biopharma Co., Ltd.

Source Genor Biopharma Co., Ltd.
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.

Overall Status Recruiting
Start Date April 24, 2017
Completion Date November 2020
Primary Completion Date August 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUC 0- t Up to 84 days
Secondary Outcome
Measure Time Frame
Cmax Up to 84 days
AUC0-∞ Up to 84 days
ADA Up to 84 days
Enrollment 84
Condition
Intervention

Intervention Type: Biological

Intervention Name: GB222

Description: 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.

Arm Group Label: GB222

Other Name: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection

Intervention Type: Biological

Intervention Name: Bevacizumab

Description: 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.

Arm Group Label: Bevacizumab

Other Name: Avastin

Eligibility

Criteria:

1. Subjects who voluntarily participated in the clinical study and sign the informed consent form;

2. Healthy male adult volunteers aged 18 to 45 years;

3. The subjects have qualified physical examination within 28 30 days before the study, the body mass index (BMI) is within the range of 19.0~24.0, 50kg for males³ and 45kg for females³, the body weight of males and females is not more than 75kg (inclusive);

4. The subjects agree and adopt reliable contraceptive methods to ensure that they have no pregnancy plain from the beginning of the study to 6 months after the end of this study;

5. Based on physical examination, medical history, vital signs, electrocardiogram, etc., the researchers determined that the body condition of participant was good;

6. The subjects can well communicate with the investigators and complete the study as required by the study.

Exclusions:

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.

Gender: Male

Gender Based: Yes

Gender Description: male only

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Yi Fang, Master Principal Investigator Peking University People's Hospital
Overall Contact

Last Name: Shawn Yu, Master

Phone: 18600332657

Email: [email protected]

Location
Facility: Status: Contact: People's Hospital of Peking University Yi Fang, Master 010-66583834 [email protected]
Location Countries

China

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: GB222

Type: Experimental

Description: 1mg/kg

Label: Bevacizumab

Type: Active Comparator

Description: 1mg/kg

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov