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

Recruiting Early Phase 1 Interventional Study
NMO Spectrum Disorder
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening 2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening 3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 in…
Contacts

Fu-Dong Shi, MD,PhD

022-60814587

Shifudong219@163.com

CONTACT