Clinical Trial

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Recruiting Early Phase 1
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-12-02; most recent amendment 2026-04-29.
Status change: Not Yet Recruiting → Recruiting 2022-04-19
Trial Details
NCT Number NCT05145361
Lead Sponsor Shanghai Pharmaceuticals Holding Co., Ltd
Conditions NMO Spectrum Disorder
Enrollment 45 participants
Start Date 2022-04-07
Primary Completion 2026-12-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-05