Pharmacokinetic bioequivalence of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using a handheld syringe or an on-body delivery system.

ABSTRACT:

Purpose

This randomized, open-label, two-arm, parallel-group, single dose, multi-center phase I study (ClinicalTrials.gov ID, NCT05275010) investigated the comparability of the pharmacokinetics of a new formulation combining pertuzumab (P) and trastuzumab (H) in one fixed-dose combination for subcutaneous injection (FDC SC) using a proprietary on-body injector (OBI) or a handheld syringe with hypodermic needle in healthy male subjects.

Methods

Healthy male subjects were randomized 1:1 to either PH FDC SC using a handheld syringe (Arm 1) or an OBI device (Arm 2). Co-primary endpoints were: (i) area under the time-concentration curve (AUC) from the start of dosing to day 63 (AUC_0-62) of serum P, (ii) maximum serum concentration (C_max) from start of dosing

SUBMITTER: Wynne C 

PROVIDER: S-EPMC12165970 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature