drugset / Trial / NCT04896541
Phase I Double-blind, Placebo-controlled Study of AZD7442
RandomizedParallel-groupTriple-blindPrevention
Summary
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
Timeline
- Start
- 2021-03-16
- Primary completion
- 2022-06-14
- Completion
- 2022-06-14
Publications
- Okada H, Ishikawa K, Itoh Y, Noda Y, Eto T, Pilla Reddy V, Chen CC, Gibbs M, Johnsson E. Safety, tolerability, and pharmacokinetics of half-life extended SARS-CoV-2-neutralizing monoclonal antibodies AZD7442 (tixagevimab/cilgavimab) in healthy Japanese adults. J Infect Chemother. 2023 Nov;29(11):1061-1067. doi: 10.1016/j.jiac.2023.07.014. Epub 2023 Jul 29.
- 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 | cilgavimab | Monoclonal antibody | — | Intramuscular |
| Subject | tixagevimab | Monoclonal antibody | — | Intramuscular |