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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Omalizumab

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMAB007; 75mg×2	Drug: Omalizumab; Biological: CMAB007 Biological: Xolair
Active Comparator: Xolair; 150mg	Drug: Omalizumab; Biological: CMAB007 Biological: Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetic Outcome Measures [Cmax]	Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.	up to day 106

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Outcome Measures [Tmax]	Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects	up to day 106
Pharmacokinetic Outcome Measures [t1/2]	Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects	up to day 106
Pharmacokinetic Outcome Measures [λz]	Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects	up to day 106
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
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
Incidence of Treatment-Emergent Adverse Events [Safety]	Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects	up to day 106
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
Pharmacokinetic Outcome Measures [Vd/F]	Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects	up to day 106
Immunogenicity	the Immunogenicity of CMAB007 and Xolair in healthy subjects.	up to day 106

Collaborators and Investigators

• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CMAB007-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No