drugset / Trial / NCT05275660
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
Timeline
- Start
- 2021-05-09
- Primary completion
- 2022-02-22
- Completion
- 2022-02-22
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.
- Li S, Wu X, Li N, Cao G, Wang J, Chen Y, Li S, He J, Wu J, Yang H, Lin K, Qiu C, Liu A, Zhou H, Adrian F, Schweizer L, Zhang W, Gu J, Zhang J. Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study. Front Pharmacol. 2023 May 23;14:1117293. doi: 10.3389/fphar.2023.1117293. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HFB30132A | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | HFB30132A | Monoclonal antibody | 2000 mg | Intravenous |
Indications
No indication recorded.