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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778137
• Other study ID #: CMAB007-001
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: January 2021
• Source: Taizhou Mabtech Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 25, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab
Biological: CMAB007 Biological: Xolair

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Mabtech Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Outcome Measures [AUC0-inf]	Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.	up to day 106
Primary	Pharmacokinetic Outcome Measures [Cmax]	Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.	up to day 106
Secondary	Pharmacokinetic Outcome Measures [Tmax]	Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Pharmacokinetic Outcome Measures [t1/2]	Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Pharmacokinetic Outcome Measures [?z]	Terminal elimination rate constant (?z) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]	Apparent total body clearance (CL/F) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Pharmacodynamics [IgE levels]	Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects	up to day 106
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety]	Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Pharmacokinetic Outcome Measures [AUC0-t]	Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-t) of CMAB007 and Xolair in healthy subjects.	up to day 106
Secondary	Pharmacokinetic Outcome Measures [Vd/F]	Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects	up to day 106
Secondary	Immunogenicity	the Immunogenicity of CMAB007 and Xolair in healthy subjects.	up to day 106