drugset / Trial / NCT05184062
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
RandomizedParallel-groupTriple-blindOther
Summary
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).
Timeline
- Start
- 2021-12-03
- Primary completion
- 2022-08-15
- Completion
- 2023-05-06
Publications
- Zhang J, Zhang H, Zhang Y, Liu S, Ge X, Zhang H, Li Y, Chen CC, Stepanov O, Tang W, Zhang W. Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect. Clin Pharmacol Drug Dev. 2025 Nov;14(11):846-855. doi: 10.1002/cpdd.1586. Epub 2025 Sep 5.
- Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cilgavimab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | tixagevimab | Monoclonal antibody | 300 mg | Intravenous |