Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05145361
EARLY_PHASE1

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

Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

B001 injection

B001 injection 50mg/5mL Intravenous solution

BIOLOGICAL

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