Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study
Xiaojie Wu, Nanyang Li, Guoqin Wang, Wei Liu, Jicheng Yu, Guoying Cao, Jingjing Wang, Yuancheng Chen, Juan Ma, Jufang Wu, Haijing Yang, Xiaomeng Mao, Jinjie He, Yiqi Yu, Chao Qiu, Ning Li, Sheng Yao, Hui Feng, Jinghua Yan, Wenhong Zhang, Jing Zhang
Abstract
) value did not differ among different dose cohorts and was estimated to be around 4 weeks. Etesevimab was well tolerated after administration of a single dose at a range of 2.5 mg/kg to 50 mg/kg in healthy Chinese adults. The PK profiles of etesevimab in healthy volunteers showed typical monoclonal antibody distribution and elimination characteristics. (This study has been registered at ClinicalTrials.gov under identifier NCT04441918.).
Topics & Concepts
TolerabilityPlaceboPharmacokineticsMedicineImmunogenicityAdverse effectPharmacodynamicsInternal medicinePharmacologyAnesthesiaImmunologyAntibodyPathologyAlternative medicineSARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesComputational Drug Discovery Methods