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

NCT05232396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Beijing VDJBio Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Zhanguo Li, M.D. · Peking University People's Hospital

  • Yi Fang, PhD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-10-27
Completion
2022-02-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232396 on ClinicalTrials.gov