NCT04178044 - Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

April 30, 2021

Conditions

Bone Tumor

Interventions

BIOLOGICAL

GB223,7mg/kg

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

BIOLOGICAL

GB223,21mg/kg

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.

BIOLOGICAL

GB223,63mg/kg

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.

BIOLOGICAL

GB223,119mg/kg

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.

BIOLOGICAL

GB223,140mg/kg

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.

Trial Locations (1)

510700

RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou