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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB223-group 1 | Experimental | Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg,single dose administration; 2 subjects receive placebo. |
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| GB223-group 2 | Experimental | 21mg/kg |
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| GB223-group 3 | Experimental | 63mg/kg |
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| GB223-group 4 | Experimental | 119mg/kg |
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| GB223-group 5 | Experimental | 140mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB223,7mg/kg | Biological | Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg 2 subjects receive placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effect, AE | Adverse Effect, AE | Up to 252 days |
| Serious Adverse Effect, SAE | Serious Adverse Effect, SAE | Up to 252 days |
| AUC0-t | AUC0-t | Up to 252 days |
| Cmax | Cmax | Up to 252 days |
| AUC0-∞ | AUC0-∞ | Up to 252 days |
| Tmax | Tmax | Up to 252 days |
| Vz/F | Vz/F | Up to 252 days |
| Ke | Ke | Up to 252 days |
| MRT | MRT | Up to 252 days |
| t1/2z | t1/2z | Up to 252 days |
| Measure | Description | Time Frame |
|---|---|---|
| AntiDrug Antibody, ADA | AntiDrug Antibody, ADA | Up to 252 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Yu, Master | Contact | 010-65260820 | Shawn.Yu@genorbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Liu, Bachelor | Fifth Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37278972 | Derived | Li C, Liu H, Liao Y, Zhu Y, Tian J, Wang X, Hu Z, Zhan Y, Li X, Liang X, He J, Li Y, Shang D, Zheng Q, Wang T, Song H, Fang Y. Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults. BioDrugs. 2023 Sep;37(5):721-735. doi: 10.1007/s40259-023-00604-7. Epub 2023 Jun 6. |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| GB223,21mg/kg | Biological | 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. |
|
|
| GB223,63mg/kg | Biological | 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. |
|
|
| GB223,119mg/kg | Biological | 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. |
|
|
| GB223,140mg/kg | Biological | 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. |
|
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| CLz/F | CLz/F | Up to 252 days |