Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227470
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-11-21
Brief Title:
A Study of HBM9161 in NMOSD Patients
Sponsor:
Harbour BioMed Guangzhou Co Ltd
Organization:
Harbour BioMed Guangzhou Co Ltd
Study Overview
Official Title:
Safety Tolerability Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders NMOSD in China
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Primary ObjectivesTo investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China
Detailed Description:
This is an open-label dose exploration studyThe investigational drug is HBM9161 injection and the indication is NMOSD
HBM9161HL161BKN is a human monoclonal antibody HBM9161 targets the neonatal Fc receptor FcRn By blocking the FcRn IgG-Fc binding site and accelerating the degradation of IgG it can significantly reduce the total IgG level in blood including pathological IgGThe serum aquaporin 4 antibody AQP4-IgG associated with NMOSD is a pathological IgG so the combination of standard of care which is intravenous methylprednisolone ivMP with HBM9161 is expected to rapidly reduce AQP4-IgG levels
Two dose groups 340 mg and 680 mg were planned and each dose group plans to enroll approximately 6 subjects All subjects are weekly administered the HBM9161 by subcutaneous injection for a period of 4 weeks together with standard of care which is of intravenous methylprednisolone ivMP by subcutaneous for a period of 4 weeks The study will investigate the safety and tolerability pharmacodynamics and efficacy of HBM 9161 in patients with attack of NMOSD in China
HBM9161HL161BKN is a human monoclonal antibody HBM9161 targets the neonatal Fc receptor FcRn By blocking the FcRn IgG-Fc binding site and accelerating the degradation of IgG it can significantly reduce the total IgG level in blood including pathological IgGThe serum aquaporin 4 antibody AQP4-IgG associated with NMOSD is a pathological IgG so the combination of standard of care which is intravenous methylprednisolone ivMP with HBM9161 is expected to rapidly reduce AQP4-IgG levels
Two dose groups 340 mg and 680 mg were planned and each dose group plans to enroll approximately 6 subjects All subjects are weekly administered the HBM9161 by subcutaneous injection for a period of 4 weeks together with standard of care which is of intravenous methylprednisolone ivMP by subcutaneous for a period of 4 weeks The study will investigate the safety and tolerability pharmacodynamics and efficacy of HBM 9161 in patients with attack of NMOSD in China
Study Oversight
Has Oversight DMC:
None
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?:
None