The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

Study Overview
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Brief Summary
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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.

Official Title
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The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

Conditions
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Asthma

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject between the ages of 18 and 45 years. Subject with a body weight of ≥50 kg and ≤ 75kg and a BMI between 19.0 26.0 kg/m2 (both inclusive). Exclusion Criteria: subject has a medical history and/or current presence of disease subject has undergone surgery within three months before signing the informed consent; Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 unites of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive; Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results; Those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results; Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover); Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day; Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, etc.) and health care products within 4 weeks befor signing the informed consent; Those who have a blood donation over 400 ml within 3 months, or 200 ml within 1 month before signing the informed consent, or plan to donate blood during the trail; Those who accept any biological drugs within 3 months, or anti-IgE biological drugs within 12 months before signing the informed consent; Those who plan to donate sperm within 6 months after the administration of the test drug; Participants in other clinical trails within 3 months before signing the informed consent; Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponerma pallidum antibody is positive; The results of medical examination (ECG, X-ray, B-ultrasonic, physical and laboratory examination) are clinical significant abnormalities according to the judgment of the researcher; Anti-nuclear antibody or fecal parasite test is positive; Those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMAB007<br>75mg×2 | Drug: Omalizumab<br>* Biological: CMAB007 Biological: Xolair<br>|
| Active Comparator: Xolair<br>150mg | Drug: Omalizumab<br>* Biological: CMAB007 Biological: Xolair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |