A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
114
Biological: CMAB007 Biological: Xolair
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Pharmacokinetic Outcome Measures [AUC0-inf]
Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Cmax]
Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Tmax]
Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects
Time frame: up to day 106
Pharmacokinetic Outcome Measures [t1/2]
Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects
Time frame: up to day 106
Pharmacokinetic Outcome Measures [λz]
Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
Apparent total body clearance (CL/F) of CMAB007 and Xolair in healthy subjects
Time frame: up to day 106
Pharmacodynamics [IgE levels]
Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
Time frame: up to day 106
Incidence of Treatment-Emergent Adverse Events [Safety]
Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects
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Time frame: up to day 106
Pharmacokinetic Outcome Measures [AUC0-t]
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-t) of CMAB007 and Xolair in healthy subjects.
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Vd/F]
Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects
Time frame: up to day 106
Immunogenicity
the Immunogenicity of CMAB007 and Xolair in healthy subjects.
Time frame: up to day 106