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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
B001 injection 50mg/5mL Intravenous solution
Placebo 5mL Intravenous solution
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFirst Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITINGTangdu hospital,fourth military medical university
Xi’an, Shanxi, China
Dose-limiting toxicity (DLT)
Measurement of DLT in all subjects.
Time frame: Up to 18 days.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
Time frame: Up to 1 year
Maximum serum concentration (Cmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Time of maximum serum concentration (Tmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTime frame: Through study completion, up to 2 years
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Terminal rate constant(λz) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Half-life (t1/2) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Total clearance(CL) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Volume of distribution(Vz) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Time frame: Through study completion, up to 2 years
Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)
Time frame: Through study completion, up to 2 years
Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period
Time frame: Through study completion, up to 2 years
Change in Expanded Disability Status Scale (EDSS) Score
The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score.
Time frame: Through study completion, up to 2 years
Time to EDSS Worsening
Time frame: Through study completion, up to 2 years