Pharmacokinetic equivalence of CT-P39 and reference omalizumab in healthy individuals: A randomised, double-blind, parallel-group, Phase 1 trial.

ABSTRACT:

Background

CT-P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT-P39 to European Union-approved and United States-licensed reference omalizumab (EU- and US-omalizumab, respectively).

Methods

This two-part, randomised, parallel-group, double-blind Phase 1 trial (NCT04018313) was conducted in healthy individuals with a total immunoglobulin E (IgE) level ≤100  international units (IU)/ml at screening. In part 2, described herein, participants were randomised (1:1:1) to receive a single 150 mg subcutaneous dose of CT-P39, EU-omalizumab, or US-omalizumab. The primary endpoint was pharmacokinetic equivalence in terms of area under the concentration-time curve (AUC) from time zero to the last quantifiable

SUBMITTER: Maurer M 

PROVIDER: S-EPMC9665328 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature