Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

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.

Timeline

Start

2018-11-16

Primary completion

2020-12

Completion

2021-04

Publications

• 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.

Drugs

Indications