A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, PD, safety, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
Shanghai Xuhui Central Hospital
Shanghai, China
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of Omalizumab
Time frame: up to 2520 hours
Maximum Concentration of Omalizumab
Maximum Concentration of Omalizumab After the Single Injection of Omalizumab
Time frame: up to 2520 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours After the Single Injection of Omalizumab
Time frame: up to 2520 hours
Time to Maximum Concentration of Omalizumab
Time to Maximum Concentration of Omalizumab after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Half time
Half-time after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Terminal elimination rate constant (λz)
Terminal elimination rate constant (λz) after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Apparent total body clearance (CL/F)
Apparent total body clearance (CL/F) after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Apparent total distribution (Vd/F)
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Apparent total distribution (Vd/F) after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Immunoglobulin E levels
Free IgE in the serum samples from subjects
Time frame: up to 2520 hours
anti-drug antibodies (ADA)
ADA Positive Rate after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Neutralization antibodies (Nab)
Neutralizing Antibody Positive Rate after the Single Injection of Omalizumab
Time frame: up to 2520 hours
Percentage and Severity of Participants with Adverse Events
Total Frequency and Severity of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Time frame: up to 2520 hours