This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.
This is a Phase 1, open-label, dose-escalation study in NMOSD patients in which subjects will receive BAT4406F injection via intravenous infusion. A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The overall objective is to assess the safety, tolerability, and pharmacokinetics of BAT4406F injection in NMOSD patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Dose-limiting toxicity(DLT)
Safety and tolerability endpoint
Time frame: 4weeks
Maximum tolerated dosed (MTD)
Safety and tolerability endpoint
Time frame: up to 6 months
Area under the curve (AUC)
Pharmacokinetic endpoint
Time frame: up to 6 months
Maximum serum drug concentration (Cmax)
Pharmacokinetic endpoint
Time frame: up to 6 months
Half-life period(t1/2)
Pharmacokinetic endpoint
Time frame: up to 6 months
Maximum serum drug time (Tmax)
Pharmacokinetic endpoint
Time frame: up to 6 months
CD19+ B lymphocyte ratio
Pharmacodynamics endpoint
Time frame: up to 6 months
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