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
Yinjuan Li, Qi Lu, Haihong Bai, Chunyun Sun, Shuping Xu, Yu Wang, Chunyu Han, Yan Li, Long Liu, Xiaoqiang Cheng, Ju Liu, Chunpu Lei, Yuanxu Tong, Ming‐Li Sun, Lixin Yan, Weiqiu Chen, Xi-Sheng Liu, Qing Liu, Liangzhi Xie, Xinghe Wang
Abstract
and AUC parameters. An antidrug antibody response was detected in four (16.0%) participants receiving SCTA01, with low titers, between the baseline and day 28, but all became negative later. In conclusion, SCTA01 up to 50 mg/kg was safe and well-tolerated in healthy participants. Its PK parameters were nearly linear dose-proportional. (This study has been registered at ClinicalTrials.gov under identifier NCT04483375.).
Topics & Concepts
ImmunogenicityTolerabilityPharmacokineticsMonoclonal antibodyMedicinePlaceboPharmacologyCoronavirus disease 2019 (COVID-19)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)PharmacodynamicsAntibodyVirologyAdverse effectImmunologyInternal medicinePathologyInfectious disease (medical specialty)Alternative medicineDiseaseSARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesInhalation and Respiratory Drug Delivery