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Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

Primary Purpose

Bone Tumor

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GB223,7mg/kg
GB223,21mg/kg
GB223,63mg/kg
GB223,119mg/kg
GB223,140mg/kg
Sponsored by
Genor Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Tumor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Understand the study procedures and contents, and voluntarily sign the informed consent form;
  2. Aged from 18 to 65 years at ICF signing (inclusive), males or females;
  3. At screening, the male body weight≥50kg, female body weight ≥45kg, the body weight of males and females is not more than 75kg (inclusive), body mass index (BMI) is within the range between 19 and 24.0 (both inclusive);
  4. The following tests are normal, or the abnormalities are not clinically significant at screening: physical examination, vital sign, laboratory tests, ECG test, chest radiography and CT tests of upper and middle abdomen, PPD test and CT test of oral cavity;
  5. The subjects and their partners agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 12 months after the administration of investigational products.
  6. The subjects can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study.

Exclusion Criteria:

  1. Lactating and pregnant women;
  2. Subjects who have pregnancy plan within 12 months;
  3. Subjects who currently or previously have osteomyelitis or osteonecrosis of jaws, or subjects who plan to receive invasive dental surgery or jaw surgery, or subjects whose wounds are not cured after dental or oral surgeries;
  4. Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects who have medical history of psychiatric disorders; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension;
  5. Any of the following is met: 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) test;
  6. Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
  7. Subjects who have medical history of drug addiction or drug abuse;
  8. Smoking more than 5 cigarettes/day or equivalent tobacco; or subjects who cannot stop smoking during the study period;
  9. Weekly alcohol consumption more than 28 units (1 unit = 285 mL of beer or 25 mL of spirits or 100 mL of wine); or subjects who have positive breath alcohol test within 24 hours before the use of investigational drug;
  10. Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5xULN, serum creatinine (Cr) > 1.0xULN;
  11. Abnormal routine blood tests: any of the following is met: white blood cells (WBC)<3.0×109/L or >9.15×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT)<100×109/L, hemoglobin (HGB)<113g/L;
  12. Abnormal serum calcium: current hypocalcaemia or hypercalcemia, or albumin-corrected serum calcium level is not within the normal laboratory range.
  13. 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);
  14. Subjects with abnormal thyroid and parathyroid function and diseases affecting bone metabolism such as rheumatoid arthritis and osteomalacia;
  15. Subjects with recent fracture (within 6 months);
  16. Subjects with positive tumor markers (CEA, AFP, PSA and CA-125);
  17. Patients who previously or currently have malignant tumors within 5 years before screening (excluding adequately treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical in situ carcinoma);
  18. 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;
  19. Participated in clinical studies of similar investigational products such as denosumab etc.;
  20. Use of drugs which may affect bone metabolism within 4 weeks or 5 half-lives (whichever is longer) before this study and the use of drugs which may affect bone metabolism during this study period; These drugs include but are not limited to the following drugs: contraceptives containing estrogen, bisphosphonate, fluoride, hormone replacement therapies (i.e., tibolone, estrogen, estrogenic compounds such as raloxifen), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000IU/day), glucocorticoids (use of inhaled or local glucocorticoid 2 weeks before enrollment), anabolic hormone drugs (e.g., metandienone, nandrolone phenylpropionate, hydroxymetholone, stanozolol, nandrolone decanoate, danazolum), calcitriol and diuretics;
  21. Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.

Sites / Locations

  • The Fifth Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

GB223-group 1

GB223-group 2

GB223-group 3

GB223-group 4

GB223-group 5

Arm Description

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg,single dose administration; 2 subjects receive placebo.

21mg/kg

63mg/kg

119mg/kg

140mg/kg

Outcomes

Primary Outcome Measures

Adverse Effect, AE
Adverse Effect, AE
Serious Adverse Effect, SAE
Serious Adverse Effect, SAE
AUC0-t
AUC0-t
Cmax
Cmax
AUC0-∞
AUC0-∞
Tmax
Tmax
Vz/F
Vz/F
Ke
Ke
MRT
MRT
t1/2z
t1/2z
CLz/F
CLz/F

Secondary Outcome Measures

AntiDrug Antibody, ADA
AntiDrug Antibody, ADA

Full Information

First Posted
November 24, 2019
Last Updated
November 24, 2019
Sponsor
Genor Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04178044
Brief Title
Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection
Official Title
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetic(PK) and Pharmacodynamic(PD) of GB223 in Healthy Adult Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genor Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single dose of GB223 in healthy subjects; the secondary objective is to evaluate the immunogenicity and pharmacodynamic (PD) profiles of single dose of GB223 in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GB223-group 1
Arm Type
Experimental
Arm Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg,single dose administration; 2 subjects receive placebo.
Arm Title
GB223-group 2
Arm Type
Experimental
Arm Description
21mg/kg
Arm Title
GB223-group 3
Arm Type
Experimental
Arm Description
63mg/kg
Arm Title
GB223-group 4
Arm Type
Experimental
Arm Description
119mg/kg
Arm Title
GB223-group 5
Arm Type
Experimental
Arm Description
140mg/kg
Intervention Type
Biological
Intervention Name(s)
GB223,7mg/kg
Other Intervention Name(s)
Placebo
Intervention Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg 2 subjects receive placebo.
Intervention Type
Biological
Intervention Name(s)
GB223,21mg/kg
Other Intervention Name(s)
Placebo
Intervention Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:21mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
Intervention Type
Biological
Intervention Name(s)
GB223,63mg/kg
Other Intervention Name(s)
Placebo
Intervention Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:63mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
Intervention Type
Biological
Intervention Name(s)
GB223,119mg/kg
Other Intervention Name(s)
Placebo
Intervention Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:119mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
Intervention Type
Biological
Intervention Name(s)
GB223,140mg/kg
Other Intervention Name(s)
Placebo
Intervention Description
Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:140mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
Primary Outcome Measure Information:
Title
Adverse Effect, AE
Description
Adverse Effect, AE
Time Frame
Up to 252 days
Title
Serious Adverse Effect, SAE
Description
Serious Adverse Effect, SAE
Time Frame
Up to 252 days
Title
AUC0-t
Description
AUC0-t
Time Frame
Up to 252 days
Title
Cmax
Description
Cmax
Time Frame
Up to 252 days
Title
AUC0-∞
Description
AUC0-∞
Time Frame
Up to 252 days
Title
Tmax
Description
Tmax
Time Frame
Up to 252 days
Title
Vz/F
Description
Vz/F
Time Frame
Up to 252 days
Title
Ke
Description
Ke
Time Frame
Up to 252 days
Title
MRT
Description
MRT
Time Frame
Up to 252 days
Title
t1/2z
Description
t1/2z
Time Frame
Up to 252 days
Title
CLz/F
Description
CLz/F
Time Frame
Up to 252 days
Secondary Outcome Measure Information:
Title
AntiDrug Antibody, ADA
Description
AntiDrug Antibody, ADA
Time Frame
Up to 252 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Understand the study procedures and contents, and voluntarily sign the informed consent form; Aged from 18 to 65 years at ICF signing (inclusive), males or females; At screening, the male body weight≥50kg, female body weight ≥45kg, the body weight of males and females is not more than 75kg (inclusive), body mass index (BMI) is within the range between 19 and 24.0 (both inclusive); The following tests are normal, or the abnormalities are not clinically significant at screening: physical examination, vital sign, laboratory tests, ECG test, chest radiography and CT tests of upper and middle abdomen, PPD test and CT test of oral cavity; The subjects and their partners agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 12 months after the administration of investigational products. The subjects can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study. Exclusion Criteria: Lactating and pregnant women; Subjects who have pregnancy plan within 12 months; Subjects who currently or previously have osteomyelitis or osteonecrosis of jaws, or subjects who plan to receive invasive dental surgery or jaw surgery, or subjects whose wounds are not cured after dental or oral surgeries; Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects who have medical history of psychiatric disorders; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension; Any of the following is met: 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) test; Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.) Subjects who have medical history of drug addiction or drug abuse; Smoking more than 5 cigarettes/day or equivalent tobacco; or subjects who cannot stop smoking during the study period; Weekly alcohol consumption more than 28 units (1 unit = 285 mL of beer or 25 mL of spirits or 100 mL of wine); or subjects who have positive breath alcohol test within 24 hours before the use of investigational drug; Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5xULN, serum creatinine (Cr) > 1.0xULN; Abnormal routine blood tests: any of the following is met: white blood cells (WBC)<3.0×109/L or >9.15×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT)<100×109/L, hemoglobin (HGB)<113g/L; Abnormal serum calcium: current hypocalcaemia or hypercalcemia, or albumin-corrected serum calcium level is not within the normal laboratory range. 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); Subjects with abnormal thyroid and parathyroid function and diseases affecting bone metabolism such as rheumatoid arthritis and osteomalacia; Subjects with recent fracture (within 6 months); Subjects with positive tumor markers (CEA, AFP, PSA and CA-125); Patients who previously or currently have malignant tumors within 5 years before screening (excluding adequately treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical in situ carcinoma); 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; Participated in clinical studies of similar investigational products such as denosumab etc.; Use of drugs which may affect bone metabolism within 4 weeks or 5 half-lives (whichever is longer) before this study and the use of drugs which may affect bone metabolism during this study period; These drugs include but are not limited to the following drugs: contraceptives containing estrogen, bisphosphonate, fluoride, hormone replacement therapies (i.e., tibolone, estrogen, estrogenic compounds such as raloxifen), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000IU/day), glucocorticoids (use of inhaled or local glucocorticoid 2 weeks before enrollment), anabolic hormone drugs (e.g., metandienone, nandrolone phenylpropionate, hydroxymetholone, stanozolol, nandrolone decanoate, danazolum), calcitriol and diuretics; Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn Yu, Master
Phone
010-65260820
Email
Shawn.Yu@genorbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan Liu, Bachelor
Organizational Affiliation
Fifth Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Liu
Phone
13802736049
Email
haiyanliu36049@Yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

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