The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
- Registration Number
- NCT04778137
- Lead Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 114
- 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).
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CMAB007 Omalizumab 75mg×2 Xolair Omalizumab 150mg
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Pharmacokinetic Outcome Measures [Tmax] up to day 106 Time to Cmax (Tmax) 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
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.
Pharmacokinetic Outcome Measures [t1/2] up to day 106 Terminal half-life (t1/2) 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
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital
🇨🇳Shanghai, Shanghai, China