drugset / Trial / NCT05345522
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.
Timeline
- Start
- 2022-04-18
- Primary completion
- 2022-11-27
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody | Monoclonal antibody | 8 mg/kg | Intravenous |