Overview

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

Status:
Completed
Trial end date:
2021-05-25
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Taizhou Mabtech Pharmaceutical Co.,Ltd
Treatments:
Omalizumab
Criteria
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;