Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites.

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Tác giả: Melissa Aldinger, Alicia Aylott, Asma El-Zailik, Chad Garner, Erik Mogalian, Jennifer Moore, Sergio Parra, Amanda Peppercorn, Maribel Reyes, Jennifer Sager, Yasmin Sánchez-Pearson, Prosenjit Sarkar, Andrew Skingsley, Qianwen Wang

Ngôn ngữ: eng

Ký hiệu phân loại: 531.112 Kinematics

Thông tin xuất bản: United States : Clinical pharmacology and therapeutics , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 188879

 Sotrovimab is a recombinant human monoclonal antibody for the early treatment of mild-to-moderate COVID- 19. A phase I, open-label, randomized, parallel-group study was conducted to investigate the pharmacokinetics, relative bioavailability, safety, and tolerability of two concentrations of sotrovimab administered intramuscularly at different injection sites in healthy volunteers. The study consisted of three parts (A, B, and C) and the pharmacokinetic results from Part A are reported herein. In Part A, participants were randomized in a 2:2:1:1 ratio to a 500 mg dose of 62.5 mg/mL sotrovimab administered into dorsogluteal muscle, or 100 mg/mL sotrovimab administered into dorsogluteal, anterolateral thigh, or deltoid muscles. Formulation concentration did not impact exposure following dorsogluteal administration
  the point estimates (90% confidence interval [CI]) of the geometric mean ratios (GMRs) of area under the curve (AUC)
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