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

NCT04778137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-10-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Omalizumab

Biological: CMAB007 Biological: Xolair

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-04-26
Completion
2021-05-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778137 on ClinicalTrials.gov