Asthma
Conditions
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.
Interventions
DRUGOmalizumab
Biological: CMAB007 Biological: Xolair
Sponsors
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pharmacokinetic Outcome Measures [Tmax] | up to day 106 | Time to Cmax (Tmax) 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. |
| 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 [t1/2] | up to day 106 | Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects |
Countries
China
Outcome results
None listed