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

Sponsor
Beijing VDJBio Co., LTD.
Study ID
NCT05232396
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Feb 2022
Primary completion
Oct 27, 2021
Completion
Feb 25, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IL-6R Monoclonal Antibody Injection 4mg/kg
    IL-6R Monoclonal Antibody Injection 4mg/kg, single dose usage
  • Experimental: IL-6R Monoclonal Antibody Injection 6mg/kg
    IL-6R Monoclonal Antibody Injection 6mg/kg, single dose usage
  • Experimental: IL-6R Monoclonal Antibody Injection 8mg/kg
    IL-6R Monoclonal Antibody Injection 8mg/kg, single dose usage
  • Active Comparator: Tocilizumab Injection 8mg/kg
    Tocilizumab Injection 8mg/kg，as active comparator, single dose usage.

Primary Outcome Measure

Safety as measured by patients with adverse events [ Time Frame: First dose up to last follow-up visit(Day1-Day57) ]

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