Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.

ABSTRACT:

Aims

To demonstrate pharmacokinetic equivalence of CT‑P39 administered via auto-injector (CT‑P39 AI) and European Union-approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults.

Participants & methods

This open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC_0-inf) and maximum serum concentration (C_max). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80-125% equivalence margin. Secondary endpoints comprised additional pharmacok

SUBMITTER: Hasunuma T 

PROVIDER: S-EPMC11901399 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature