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

NCT ID: NCT04778137

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-25

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

CMAB007

75mg×2

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

Biological: CMAB007 Biological: Xolair

Xolair

150mg

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

Biological: CMAB007 Biological: Xolair

Interventions

Omalizumab

Biological: CMAB007 Biological: Xolair

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taizhou Mabtech Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CMAB007-001

Identifier Type: -

Identifier Source: org_study_id