The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

Mabpharm

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: Omalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04778137

CMAB007-001

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

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;