Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2022-04-07
Completion Date
2025-12-15
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
B001 injection
B001 injection 50mg/5mL Intravenous solution
Placebo
Placebo 5mL Intravenous solution
Locations (4)
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tangdu hospital,fourth military medical university
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China