Clinical trial NCT04778137: The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
Official title: The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-02
Enrollment: 114
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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:

* 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;

Primary outcomes:
measure: Pharmacokinetic Outcome Measures [AUC0-inf]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [Cmax]
timeFrame: up to day 106
Secondary outcomes:
measure: Pharmacokinetic Outcome Measures [Tmax]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [t1/2]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [λz]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
timeFrame: up to day 106
measure: Pharmacodynamics [IgE levels]
timeFrame: up to day 106
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [AUC0-t]
timeFrame: up to day 106
measure: Pharmacokinetic Outcome Measures [Vd/F]
timeFrame: up to day 106
measure: Immunogenicity
timeFrame: up to day 106
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: