Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Monoclonal Antibody (SCTA01) Targeting SARS-CoV-2 in Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, Phase I Study

Author:

Li Yinjuan1,Qi Lu1,Bai Haihong1,Sun Chunyun234,Xu Shuping2,Wang Yu1,Han Chunyu1,Li Yan1,Liu Long1,Cheng Xiaoqiang1,Liu Ju1,Lei Chunpu1,Tong Yuanxu1,Sun Mingli1,Yan Lixin2,Chen Weiqiu2,Liu Xisheng2,Liu Qing2,Xie Liangzhi234,Wang Xinghe1ORCID

Affiliation:

1. Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China

2. Sinocelltech Ltd., Beijing, China

3. Beijing Engineering Research Center of Protein and Antibody, Beijing, China

4. Cell Culture Engineering Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

Abstract

SCTA01 is a novel monoclonal antibody with promising prophylactic and therapeutic potential for COVID-19. This study aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of SCTA01 in healthy adults.

Funder

Beijing Municipal Science and Technology Project

National Science and Technology Major Project

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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