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)
Who is this study for? Patients with aquaporin-4 antibody positive neuromyelitis optic spectrum disorder
What treatments are being studied? B001
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
• Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
• Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
• Age 18 to 70 years, inclusive at the time of informed consent
Locations
Other Locations
China
Beijing Tiantan Hospital Capital Medical University
RECRUITING
Beijing
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tangdu hospital,fourth military medical university
RECRUITING
Xi’an
Contact Information
Primary
Fu-Dong Shi, MD,PhD
Shifudong219@163.com
022-60814587
Time Frame
Start Date: 2022-04-07
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 45
Treatments
Experimental: B001 injection
Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.
Placebo_comparator: Placebo
Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pharmaceuticals Holding Co., Ltd