drugset
drugset / Trial / NCT04018313

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

NCT04018313 ↗

Phase 1 Completed 176 enrolled Celltrion
RandomizedParallel-groupQuadruple-blindOther

Summary

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Timeline

Start
2020-05-28
Primary completion
2021-03-27
Completion
2021-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody — —

Indications

No indication recorded.