Phase I Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of CMAB007 and Xolair in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects

Taizhou Mabtech Pharmaceutical Co.,Ltd1 site in 1 country114 target enrollmentFebruary 7, 2022

ConditionsHealthy Volunteers

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
Enrollment: 114
Locations: 1
Primary Endpoint: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, PD, safety, and immunogenicity.

Registry

clinicaltrials.gov

Start Date

February 7, 2022

End Date

September 13, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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

Time Frame: up to 2520 hours

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

Maximum Concentration of Omalizumab

Time Frame: up to 2520 hours

Maximum Concentration of Omalizumab After the Single Injection of Omalizumab

Secondary Outcomes

Percentage and Severity of Participants with Adverse Events(up to 2520 hours)
Time to Maximum Concentration of Omalizumab(up to 2520 hours)
Apparent total body clearance (CL/F)(up to 2520 hours)
Immunoglobulin E levels(up to 2520 hours)
Half time(up to 2520 hours)
Terminal elimination rate constant (λz)(up to 2520 hours)
Apparent total distribution (Vd/F)(up to 2520 hours)
anti-drug antibodies (ADA)(up to 2520 hours)
Neutralization antibodies (Nab)(up to 2520 hours)
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours(up to 2520 hours)