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

NCT05897008 | Completed Phase 1

• 1 other identifier: CMAB007-002
• 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, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time

  Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of Omalizumab

  up to 2520 hours

• Maximum Concentration of Omalizumab

  Maximum Concentration of Omalizumab After the Single Injection of Omalizumab

  up to 2520 hours

Secondary Outcomes (10)

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours

  up to 2520 hours

• Time to Maximum Concentration of Omalizumab

  up to 2520 hours

• Half time

  up to 2520 hours

• Terminal elimination rate constant (λz)

  up to 2520 hours

• Apparent total body clearance (CL/F)

  up to 2520 hours

Study Arms (2)

CMAB007

EXPERIMENTAL

150 mg Subcutaneous injection

Biological: CMAB007

Xolair

ACTIVE COMPARATOR

150 mg Subcutaneous injection

Biological: Xolair

Interventions

CMAB007 BIOLOGICAL

for subcutaneous injection only

CMAB007

Xolair BIOLOGICAL

for subcutaneous injection only

Xolair

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteers, age ranged 18 to 45 years (both inclusive) when sign the informed consent form.
• Subjects with body weight of ≥50 kg and ≤ 75 kg and BMI ≥20.0 and ≤ 26.0 kg/m2 (both inclusive).
• Subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; moreover, subjects can communicate well with researchers and complete the research according to the regulations.
• Subjects must be informed consent of the study and voluntarily sign informed consent form (name and time) prior to the study.

You may not qualify if:

• After medical examination (vital signs, physical examination, electrocardiogram, positive chest X-radiography, abdominal B-ultrasound, and various laboratory examinations including blood routine, urine routine, blood biochemistry and total IgE, etc.), any examination item was judged abnormal by the investigator and had clinical significance.
• Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, dermatitis eczema, 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 have a history of serious diseases including but not limited to cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, immune system, mental or nervous system (eg, epilepsy, etc), or currently have any of the above diseases or active infected diseases, or any other disease or medical condition that may interfere with the results of the trial, such as hereditary bleeding tendency, coagulation disorders or history of blood clots or bleeding.
• History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ).
• Any one of HBV surface antigen, HIV antibody, HCV antibody and treponema pallidum antibody is positive.
• Anti-nuclear antibody is positive.
• Fecal parasite test is positive.
• Those who smoke more than 10 cigarettes per day on average in the 6 months before screening.
• 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 45 ml spirits with 40% alcohol or 150 ml wine), or whose alcohol breath test is positive.
• Drug abusers, or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior the trial, or excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening, or positive urine drug screening.
• Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period.
• Use of any prescription drug, over-the-counter drug or health product or vaccine within 4 weeks prior to screening, or who plan to receive live vaccine during the study period, or prior use of drug within 5 half-lives, whichever is longer.
• Those who had lost blood or donated at least 400 mL in the 3 months prior to the screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial.
• Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study.
• Subjects and their partners were not willing to use medically approved contraceptive methods within 6 months of study administration, or partners plan to become pregnant, or subjects plan to donate sperm.

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Omalizumab

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 Officials

• Jia Jingying

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Biological: CMAB007 Biological: Xolair #Omalizumab#

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: February 7, 2022
• Primary Completion: June 27, 2022
• Study Completion: September 13, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)