NCT04178044

Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bone Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-16
• Primary completion: 2020-12-01
• Completion: 2021-04-01
• First posted: 2019-11-26
• Last updated: 2019-11-26

Locations

1 site across 1 country: China