drugset / Trial / NCT04483375
Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Timeline
- Start
- 2020-07-24
- Primary completion
- 2020-11-17
- Completion
- 2020-11-17
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper The primary outcomes were the dose-limiting toxicity (DLT) and maximal tolerable dose (MTD) PMID 34491805 ↗
paper No DLT was reported, and the MTD of SCTA01 was not reached. PMID 34491805 ↗
Publications
- Li Y, Qi L, Bai H, Sun C, Xu S, Wang Y, Han C, Li Y, Liu L, Cheng X, Liu J, Lei C, Tong Y, Sun M, Yan L, Chen W, Liu X, Liu Q, Xie L, Wang X. 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. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0106321. doi: 10.1128/AAC.01063-21. Epub 2021 Sep 7.
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UPANOVIMAB | Monoclonal antibody | 5 mg/kg | — |
| Subject | UPANOVIMAB | Monoclonal antibody | 15 mg/kg | — |
| Subject | UPANOVIMAB | Monoclonal antibody | 30 mg/kg | — |
| Subject | UPANOVIMAB | Monoclonal antibody | 50 mg/kg | — |