drugset / Trial / NCT05232396
Clinical Study of Single Dose IL-6R mAb Injection in RA Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a single-dose,multi-center, randomized, double-blind, positive-controlled and parallel group clinical study that aims to evaluate the safety,tolerability,PK/PD characteristics and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis.
Timeline
- Start
- 2021-03-02
- Primary completion
- 2021-10-27
- Completion
- 2022-02-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IL-6R Monoclonal Antibody | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | IL-6R Monoclonal Antibody | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | IL-6R Monoclonal Antibody | Monoclonal antibody | 8 mg/kg | Intravenous |
| Comparator | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |