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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAB007 | Experimental | 75mg×2 |
|
| Xolair | Active Comparator | 150mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | Biological: CMAB007 Biological: Xolair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to day 106 |
| Pharmacokinetic Outcome Measures [Cmax] | Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects. | up to day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Outcome Measures [Tmax] | Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects | up to day 106 |
| Pharmacokinetic Outcome Measures [t1/2] | Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| up to day 106 |
| Pharmacokinetic Outcome Measures [λz] | Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects | 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 | 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 | up to day 106 |
| Incidence of Treatment-Emergent Adverse Events [Safety] | Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects | 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. | up to day 106 |
| Pharmacokinetic Outcome Measures [Vd/F] | Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects | up to day 106 |
| Immunogenicity | the Immunogenicity of CMAB007 and Xolair in healthy subjects. | up to day 106 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |