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

NCT04778137 | Completed Phase 1

• 1 other identifier: CMAB007-001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Pharmacokinetic Outcome Measures [Tmax]

  up to day 106

• Pharmacokinetic Outcome Measures [t1/2]

  up to day 106

• Pharmacokinetic Outcome Measures [λz]

  up to day 106

• Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]

  up to day 106

• Pharmacodynamics [IgE levels]

  up to day 106

Study Arms (2)

CMAB007

EXPERIMENTAL

75mg×2

Drug: Omalizumab

Xolair

ACTIVE COMPARATOR

150mg

Drug: Omalizumab

Interventions

Omalizumab DRUG

Biological: CMAB007 Biological: Xolair

CMAB007; Xolair

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: December 1, 2020
• Primary Completion: April 26, 2021
• Study Completion: May 25, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)