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Clinical Trial
. 2021 Oct 18;65(11):e0106321.
doi: 10.1128/AAC.01063-21. Epub 2021 Sep 7.

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 #  1 , Lu Qi #  1 , Haihong Bai #  1 , Chunyun Sun  2   3   4 , Shuping Xu  2 , Yu Wang  1 , Chunyu Han  1 , Yan Li  1 , Long Liu  1 , Xiaoqiang Cheng  1 , Ju Liu  1 , Chunpu Lei  1 , Yuanxu Tong  1 , Mingli Sun  1 , Lixin Yan  2 , Weiqiu Chen  2 , Xisheng Liu  2 , Qing Liu  2 , Liangzhi Xie  2   3   4 , Xinghe Wang  1
Affiliations
Clinical Trial

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 et al. Antimicrob Agents Chemother. .

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.).

Keywords: COVID-19; SARS-CoV-2; monoclonal antibody; pharmacokinetics; safety.

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Figures

FIG 1
FIG 1
Mean SCTA01 serum concentrations in different dose groups. (A) Mean SCTA01 serum concentrations versus time (linear scaled) in different dose groups; (B) semilogarithmic plot of concentration-time data in different dose groups.
See this image and copyright information in PMC

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