drugset / Trial / NCT04590430
Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.
Timeline
- Start
- 2020-10-20
- Primary completion
- 2021-07-26
- Completion
- 2021-07-26
Publications
- Chen Y, Li S, Hedrich W, Wu X, Li S, Qiu C, Lin K, Bian X, He J, Zhou H, Adrian F, Schweizer L, Zhang J. Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects. Int J Antimicrob Agents. 2025 Mar;65(3):107439. doi: 10.1016/j.ijantimicag.2024.107439. Epub 2025 Jan 9.
- 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 | HFB30132A | Monoclonal antibody | 400 mg | Intravenous |
| Subject | HFB30132A | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | HFB30132A | Monoclonal antibody | 2000 mg | Intravenous |
Indications
No indication recorded.