Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2026-01-02 @ 6:16 AM
Study NCT ID:
NCT04175158
Status:
UNKNOWN
Last Update Posted:
2019-11-22
First Post:
2019-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial in Chinese Healthy Volunteers of GB222
Sponsor:
Genor Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: