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A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis

Clinical Trial Summary

This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.

Clinical Trial Description

This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 ~ day 84). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04704492
Study type Interventional
Source SinoMab Pty Ltd
Contact
Status Completed
Phase Phase 1
Start date August 14, 2012
Completion date December 16, 2013
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