Clinical Trial in Chinese Healthy Volunteers of GB222

NCT04175158 | Unknown Phase 1

• 1 other identifier: GENOR GB222-001; V1.3
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUC 0- t

  AUC 0- t

  Up to 84 days

Secondary Outcomes (3)

• Cmax

  Up to 84 days

• AUC0-∞

  Up to 84 days

• ADA

  Up to 84 days

Study Arms (2)

GB222

EXPERIMENTAL

1mg/kg

Biological: GB222

Bevacizumab

ACTIVE COMPARATOR

1mg/kg

Biological: Bevacizumab

Interventions

GB222 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.

Also known as: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection

GB222

Bevacizumab 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.

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: male only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yi Fang, Master

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

18600332657; shawn.yu@genorbio.com

Study Design

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

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 22, 2019
• Study Start: April 24, 2017
• Primary Completion: August 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)