drugset / Trial / NCT04631666
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
Phase 1/2
Completed
57 enrolled
University of Cologne
Boehringer Ingelheim · collabZKS Köln · collab
RandomizedSequentialTriple-blindTreatment
Summary
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
Timeline
- Start
- 2020-12-08
- Primary completion
- 2021-08-11
- Completion
- 2021-08-11
Publications
- Background Kreer C, Zehner M, Weber T, Ercanoglu MS, Gieselmann L, Rohde C, Halwe S, Korenkov M, Schommers P, Vanshylla K, Di Cristanziano V, Janicki H, Brinker R, Ashurov A, Krahling V, Kupke A, Cohen-Dvashi H, Koch M, Eckert JM, Lederer S, Pfeifer N, Wolf T, Vehreschild MJGT, Wendtner C, Diskin R, Gruell H, Becker S, Klein F. Longitudinal Isolation of Potent Near-Germline SARS-CoV-2-Neutralizing Antibodies from COVID-19 Patients. Cell. 2020 Sep 17;182(6):1663-1673. doi: 10.1016/j.cell.2020.08.046. No abstract available.
- 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 | DZIF-10c | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Subject | DZIF-10c | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | DZIF-10c | Monoclonal antibody | 40 mg/kg | Intravenous |