Your browser doesn't support javascript.
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.
Li, Yinjuan; Qi, Lu; Bai, Haihong; Sun, Chunyun; Xu, Shuping; Wang, Yu; Han, Chunyu; Li, Yan; Liu, Long; Cheng, Xiaoqiang; Liu, Ju; Lei, Chunpu; Tong, Yuanxu; Sun, Mingli; Yan, Lixin; Chen, Weiqiu; Liu, Xisheng; Liu, Qing; Xie, Liangzhi; Wang, Xinghe.
  • Li Y; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Qi L; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Bai H; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Sun C; Sinocelltech Ltd., Beijing, China.
  • Xu S; Beijing Engineering Research Center of Protein and Antibody, Beijing, China.
  • Wang Y; Cell Culture Engineering Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
  • Han C; Sinocelltech Ltd., Beijing, China.
  • Li Y; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Liu L; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Cheng X; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Liu J; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Lei C; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Tong Y; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Sun M; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Yan L; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Chen W; Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
  • Liu X; Sinocelltech Ltd., Beijing, China.
  • Liu Q; Sinocelltech Ltd., Beijing, China.
  • Xie L; Sinocelltech Ltd., Beijing, China.
  • Wang X; Sinocelltech Ltd., Beijing, China.
Antimicrob Agents Chemother ; 65(11): e0106321, 2021 10 18.
Article in English | MEDLINE | ID: covidwho-1398568
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; 32), cohort 2 (n = 8; 62), cohort 3, or cohort 4 (both n = 10; 82) 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.).
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Antimicrob Agents Chemother Year: 2021 Document Type: Article Affiliation country: AAC.01063-21

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Antimicrob Agents Chemother Year: 2021 Document Type: Article Affiliation country: AAC.01063-21