Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults

Author:

Shimizu Ryosuke1ORCID,Sonoyama Takuhiro2,Fukuhara Takahiro3,Kuwata Aya3,Matsuo Yumiko1,Kubota Ryuji1

Affiliation:

1. Shionogi & Co., Ltd., Clinical Pharmacology & Pharmacokinetics, Osaka, Japan

2. Shionogi & Co., Ltd., Medical Science Department, Osaka, Japan

3. Shionogi & Co., Ltd., Clinical Research Department, Osaka, Japan

Abstract

Ensitrelvir is a novel selective inhibitor of the 3C-like protease of SARS-CoV-2, which is essential for viral replication. This phase 1 study of ensitrelvir assessed its safety, tolerability, and pharmacokinetics of single (part 1, n  = 50) and multiple (part 2, n  = 33) ascending oral doses.

Funder

Shionogi

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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