The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CMAB007 75mg×2 |
Drug: Omalizumab
Biological: CMAB007 Biological: Xolair
|
| Active Comparator: Xolair 150mg |
Drug: Omalizumab
Biological: CMAB007 Biological: Xolair
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic Outcome Measures [AUC0-inf] [up to day 106]
Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
- Pharmacokinetic Outcome Measures [Cmax] [up to day 106]
Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.
Secondary Outcome Measures
- Pharmacokinetic Outcome Measures [Tmax] [up to day 106]
Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects
- Pharmacokinetic Outcome Measures [t1/2] [up to day 106]
Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects
- Pharmacokinetic Outcome Measures [λz] [up to day 106]
Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects
- Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)] [up to day 106]
Apparent total body clearance (CL/F) of CMAB007 and Xolair in healthy subjects
- Pharmacodynamics [IgE levels] [up to day 106]
Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
- Incidence of Treatment-Emergent Adverse Events [Safety] [up to day 106]
Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects
- Pharmacokinetic Outcome Measures [AUC0-t] [up to day 106]
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-t) of CMAB007 and Xolair in healthy subjects.
- Pharmacokinetic Outcome Measures [Vd/F] [up to day 106]
Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects
- Immunogenicity [up to day 106]
the Immunogenicity of CMAB007 and Xolair in healthy subjects.
Eligibility Criteria
Criteria
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:
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subject has a medical history and/or current presence of disease
-
subject has undergone surgery within three months before signing the informed consent;
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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;
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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;
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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;
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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);
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Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day;
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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;
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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;
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Those who accept any biological drugs within 3 months, or anti-IgE biological drugs within 12 months before signing the informed consent;
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Those who plan to donate sperm within 6 months after the administration of the test drug;
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Participants in other clinical trails within 3 months before signing the informed consent;
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Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponerma pallidum antibody is positive;
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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;
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Anti-nuclear antibody or fecal parasite test is positive;
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Those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Xuhui Central Hospital | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMAB007-001