Clinical Trial in Chinese Healthy Volunteers of GB222

Phase 1

• Conditions: Non-small Cell Lung Cancer
• Interventions: Biological: GB222; Biological: Bevacizumab

• Registration Number: NCT04175158
• Lead Sponsor: Genor Biopharma Co., Ltd.

Brief Summary

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-24
• Status Verified: 2019-11
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-21
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22
• Primary Completion: 2020-08
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GB222	GB222	1mg/kg
Bevacizumab	Bevacizumab	1mg/kg

Primary Outcome Measures

Name	Time	Method
AUC 0- t	Up to 84 days	AUC 0- t

Secondary Outcome Measures

Name	Time	Method
AUC0-∞	Up to 84 days	AUC0-∞
Cmax	Up to 84 days	Cmax
ADA	Up to 84 days	ADA

Trial Locations

Locations (1)

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China