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

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT04778137
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab — DRUG
    Biological: CMAB007 Biological: Xolair

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jan 2021
Primary completion
Apr 26, 2021
Completion
May 25, 2021

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: CMAB007
    75mg×2
  • Active Comparator: Xolair
    150mg

Primary Outcome Measure

Pharmacokinetic Outcome Measures [AUC0-inf] [ Time Frame: up to day 106 ]

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