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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

Authors :
Lu Qi
Chunpu Lei
Xinghe Wang
Xiaoqiang Cheng
Shuping Xu
Lixin Yan
Qing Liu
Yuanxu Tong
Yan Li
Ju Liu
Ming-Li Sun
Chunyun Sun
Chen Weiqiu
Xisheng Liu
Haihong Bai
Yu Wang
Long Liu
Chunyu Han
Liangzhi Xie
Yinjuan Li
Source :
Antimicrobial Agents and Chemotherapy
Publication Year :
2021
Publisher :
American Society for Microbiology, 2021.

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. This was a randomized, double-blind, placebo-controlled, dose escalation phase I clinical trial. Healthy adults were randomly assigned to cohort 1 (n = 5; 3:2), cohort 2 (n = 8; 6:2), cohort 3, or cohort 4 (both n = 10; 8:2) to receive SCTA01 (5, 15, 30, and 50 mg/kg, respectively) versus placebo. All participants were followed up for clinical, laboratory, PK, and immunogenicity assessments for 84 days. The primary outcomes were the dose-limiting toxicity (DLT) and maximal tolerable dose (MTD), and the secondary outcomes included PK parameters, immunogenicity, and adverse events (AE). Of the 33 participants, 18 experienced treatment-related AEs; the frequency was 52.0% (13/25) in participants receiving SCTA01 and 62.5% (5/8) in those receiving placebo. All AEs were mild. There was no serious AE or death. No DLT was reported, and the MTD of SCTA01 was not reached. SCTA01 with a dose range of 5 to 50 mg/kg had nearly linear dose-proportional increases in Cmax 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.)

Details

ISSN :
10986596, 00664804, and 04483375
Volume :
65
Database :
OpenAIRE
Journal :
Antimicrobial Agents and Chemotherapy
Accession number :
edsair.doi.dedup.....255080c396383af567f9e51c669cfc28