| Registry | NCT04778137 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: quadruple, other |
| Enrollment | 114 (Actual) |
| Sponsor | Taizhou Mabtech Pharmaceutical Co.,Ltd (Industry) |
| Conditions | Asthma |
| Interventions | Omalizumab (Drug) |
| Dates | start 2020-12-01, primary completion 2021-04-26, completion 2021-05-25, first posted 2021-03-02, last updated 2021-10-11 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Asthma All trials of Omalizumab
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CMAB007 | Experimental | Drug: Omalizumab | 75mg×2 |
| Xolair | Active comparator | Drug: Omalizumab | 150mg |
Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers
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;
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai, Shanghai Municipality | China |