Indication: Prevent Respiratory Syncytial Virus (RSV) infection
Drug: AK0610
Project Name: The multicenter, randomized, double-blind, placebo-controlled, dose-escalation phase II study will assess the safety, tolerability, and pharmacokinetics of AK0610 Injection in healthy infants in China.
Background: AK0610 is a monoclonal antibody targeting the pre-fusion F protein of RSV. It was isolated from a convalescent infant and subsequently engineered to enhance durability. Distinguished by its unique binding epitope and mechanism of action, AK0610 maintains robust neutralizing activity across RSV variants, especially RSV B strains. This study has been approved by the National Medical Products Administration (NMPA) and published on the Chinese clinical trial registration platform (Publication Number: CTR20253151).
￭ Healthy infants
￭ Age: ＜12 months
For more information, please log in to the Drug Clinical Trial Registration and Publicity Platform for information of the research centers (Registration Number:CTR20253151).
http://www.chinadrugtrials.org.cn/index.html
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