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.
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
Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
Known active infection within 3 months prior to baseline
Parallel
B001 injection
DrugB001 injection 50mg/5mL Intravenous solution
Placebo
Biological/VaccinePlacebo 5mL Intravenous solution
Dose-limiting toxicity (DLT)
Measurement of DLT in all subjects.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
Maximum serum concentration (Cmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time of maximum serum concentration (Tmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.
To characterize the PK (Pharmacokinetics) of B001.
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