drugset / Trial / NCT06021574
A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody
Phase 1
Completed
40 enrolled
The Affiliated Hospital of Qingdao University
Beijing VDJBio Co., LTD. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are: * Safety and tolerability of investigational drug. * pharmacokinetics and immunogenicity of investigational drug. Participants will receive a single intravenous administration of investigational drug or placebo. Blood samples are collected at specified time points.
Timeline
- Start
- 2019-06-28
- Primary completion
- 2020-01-06
- Completion
- 2020-01-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VDJ001 | Monoclonal antibody | 1 mg | Intravenous |
| Subject | VDJ001 | Monoclonal antibody | 2 mg | Intravenous |
| Subject | VDJ001 | Monoclonal antibody | 4 mg | Intravenous |
| Subject | VDJ001 | Monoclonal antibody | 8 mg | Intravenous |
Indications
No indication recorded.