drugset
drugset / Trial / NCT04778137

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

NCT04778137 ↗

Phase 1 Completed 114 enrolled Taizhou Mabtech Pharmaceutical Co.,Ltd
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 75 mg —
Subject Omalizumab Monoclonal antibody 150 mg —

Indications

asthma