Ignite Creation Date:
2024-05-06 @ 7:37 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02569372
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2015-10-05
Brief Title:
A Phase 1 Study of GC1102 Recombinant Hepatitis B Immunoglobulin in Chronic Hepatitis B Patients
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Prospective Open-label Dose-escalation Single-center Phase I Trial to Explore the Tolerability Safety and PharmacokineticsPharmacodynamics of GC1102 Recombinant Hepatitis B Human Immunoglobulin
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
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:
This study is SADSingle Ascending DoseMADMultiple Ascending Dose study to Explore the Tolerability Safety and PharmacokineticsPharmacodynamics of GC1102 Recombinant Hepatitis B Human Immunoglobulin in Chronic Hepatitis B Patients
Detailed Description:
GC1102 is a new recombinant hepatitis B human immunoglobulin This study is composed with 2 Parts Part A for SAD and Part B for MAD and total 4 dosing program which is escalated after confirming safety Maximum 48 subjects will be participated in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None