NCT05232396

Clinical Study of Single Dose IL-6R mAb Injection in RA Patients

A Multi-center, Randomized, Double-blind Phase Ib Clinical Study to Evaluate the Safety, Tolerability, PK/PD Characteristics and Preliminary Efficacy of IL-6R mAb Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Beijing VDJBio Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is aim to evaluate the safety, tolerability, PK/PD characteristics, immunogenicity parameters and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis. There are 4 dose groups and each group enrolls 10 patients: 4mg/kg(IL-6R mAb); 6mg/kg(IL-6R mAb); 8mg/kg(IL-6R mAb) and 8mg/kg(tocilizumab ).each patient receives a single intravenous(i.v.) dose. The infusion time is from 60 to 90 minutes (the speed can be adjusted appropriately if there are injection reactions).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	IL-6R Monoclonal Antibody Injection 4mg/kg	IL-6R Monoclonal Antibody Injection 4mg/kg i.v.,single use
BIOLOGICAL	IL-6R Monoclonal Antibody Injection 6mg/kg	IL-6R Monoclonal Antibody Injection 6mg/kg i.v. , single use
BIOLOGICAL	IL-6R Monoclonal Antibody Injection 8mg/kg	IL-6R Monoclonal Antibody Injection 8mg/kg i.v. , single use
BIOLOGICAL	Tocilizumab Injection 8mg/kg	Tocilizumab Injection 8mg/kg i.v., single use

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-10-27
• Completion: 2022-02-25
• First posted: 2022-02-09
• Last updated: 2022-03-11

Locations

5 sites across 1 country: China