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 C max 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.
【저자키워드】 COVID-19, SARS-CoV-2, Safety, monoclonal antibody, pharmacokinetics, 【초록키워드】 immunogenicity, clinical trial, Phase I, Antibody Response, monoclonal antibody, Toxicity, pharmacokinetics, Prophylactic, Laboratory, adverse events, Randomized, Adults, Cohort, adverse event, death, Mild, Placebo, parameters, placebo-controlled, monoclonal, Frequency, dose, AUC, Safe, double-blind, Tolerability, Participants, Primary outcome, Secondary outcomes, All participants, Primary outcomes, therapeutic potential, Registered, participant, secondary outcome, Dose escalation, immunogenicity assessments, C max, PK parameters, serious AE, Randomly, evaluate, healthy, reported, receiving, linear, reached, assigned, receive, increases in, All participant, baseline, immunogenicity assessment, MTD, PK parameter, those receiving placebo, tolerable, 【제목키워드】 Safety, phase, targeting,