Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers

• DOI: 10.1007/s40262-023-01319-2
• Publication Date: 2023-11-13T16:01:55Z
• Authors: Ahmed Nader; Elizabeth Alexander; Dimitra Brintziki; Amina Z. Haggag; Stephen A. Harrison; Ian A. Hawes; Marjan Hezareh; Andrew M. Lippa; Arisa Okamasa; Malek Okour; Nobuhiko Okuda; Jennifer E. Sager; Scott Segal; Yuri Shida; Andrew Skingsley; Robert Williams; Esther Y. Yoon; Daren Austin
• Keywords: Tolerability

Sotrovimab 500 mg administered by a single intravenous (IV) infusion has been granted special approval for emergency use in Japan treatment of SARS-CoV-2 infection adults and children aged ≥ 12 years weighing 40 kg. This Phase 1, single-dose study investigated the pharmacokinetics, safety, tolerability IV or intramuscular (IM) sotrovimab doses versus placebo healthy Japanese Caucasian volunteers. was two-part, randomized, placebo-controlled, single-blind study. In Part participants received matching on Day 1. 2, IM dose as two 4 mL injections. There no effect ethnicity peak total serum exposure through Week 18; after adjusting body weight, point estimate 90 % confidence interval ratio between fell within conventional bioavailability bounds (80–125%). Geometric mean Cmax AUClast following administration were higher compared with participants, even adjustment weight. Overall, well tolerated both participants. After exposures similar administration. Higher not associated any safety signals. ClinicalTrials.Gov: NCT04988152.