Pharmacokinetics of Depemokimab Delivered by Safety Syringe Device or Autoinjector in Healthy Adults: A Phase 1, Single-Dose Study.

ABSTRACT: This Phase I, randomized, multicenter, open-label, parallel-group, single-dose study assessed the relative bioavailability of the anti-interleukin-5 antibody depemokimab (100 mg) when administered subcutaneously via either a safety syringe device (SSD) or an autoinjector (AI). Healthy adult participants were randomized I:I to SSD or AI treatment arms and I:I:I to the injection site (upper arm, abdomen, or thigh). Participants were followed up for 30 weeks; blood samples were collected for pharmacokinetic (PK) assessment before dosing on Day 1 and up to Week 26. Depemokimab concentration profile as measured by plasma maximum concentration (C_max), the area under the concentration-time curve from time zero extrapolated to infinity (AUC_0-inf), PK parameters, immunogenicit

SUBMITTER: Schalkwijk S 

PROVIDER: S-EPMC11905874 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature