Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05145361
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2021-11-21
Brief Title:
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder NMOSD
Sponsor:
Shanghai Pharmaceuticals Holding Co Ltd
Organization:
Shanghai Pharmaceuticals Holding Co Ltd
Study Overview
Official Title:
A Phase Ib Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody AQP4-IgG Positive Neuromyelitis Optic Spectrum Disorder NMOSD
Status:
RECRUITING
Status Verified Date:
2023-05
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:
The objectives of this phase Ib study are to evaluate the efficacy safety pharmacokinetics pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody AQP4-IgG positive NMOSD
Detailed Description:
None
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