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

NCT04778137 — Phase 1, Completed, 114 participants, Taizhou Mabtech Pharmaceutical Co.,Ltd

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RegistryNCT04778137
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: quadruple, other
Enrollment114 (Actual)
SponsorTaizhou Mabtech Pharmaceutical Co.,Ltd (Industry)
ConditionsAsthma
InterventionsOmalizumab (Drug)
Datesstart 2020-12-01, primary completion 2021-04-26, completion 2021-05-25, first posted 2021-03-02, last updated 2021-10-11
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
CMAB007ExperimentalDrug: Omalizumab75mg×2
XolairActive comparatorDrug: Omalizumab150mg
  • Omalizumab (Drug): Biological: CMAB007 Biological: Xolair

+Outcome measures

Primary outcomes

  • Pharmacokinetic Outcome Measures [AUC0-inf] [up to day 106]: Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
  • Pharmacokinetic Outcome Measures [Cmax] [up to day 106]: Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.

Secondary outcomes

  • Pharmacokinetic Outcome Measures [Tmax] [up to day 106]: Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects
  • Pharmacokinetic Outcome Measures [t1/2] [up to day 106]: Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects
  • Pharmacokinetic Outcome Measures [λz] [up to day 106]: Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects
  • Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)] [up to day 106]: Apparent total body clearance (CL/F) of CMAB007 and Xolair in healthy subjects
  • Pharmacodynamics [IgE levels] [up to day 106]: Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
  • Incidence of Treatment-Emergent Adverse Events [Safety] [up to day 106]: Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects
  • Pharmacokinetic Outcome Measures [AUC0-t] [up to day 106]: Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-t) of CMAB007 and Xolair in healthy subjects.
  • Pharmacokinetic Outcome Measures [Vd/F] [up to day 106]: Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects
  • Immunogenicity [up to day 106]: the Immunogenicity of CMAB007 and Xolair in healthy subjects.

+Eligibility

Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers

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;

+Locations (1)

FacilityCityCountryStatus
Shanghai Xuhui Central HospitalShanghai, Shanghai MunicipalityChina