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

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Tác giả: Sei Choi, Jeff Min, Stein Schalkwijk, Anusmita Sen, Brian Spears, Kai Wang, Chiara Zecchin

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : Clinical pharmacology in drug development , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 701656

 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
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