NCT04704492

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: SinoMab BioScience Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Biological: SM03	Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2

Timeline

• Start date: 2012-08-14
• Primary completion: 2013-12-16
• Completion: 2013-12-16
• First posted: 2021-01-11
• Last updated: 2021-01-11

Locations

1 site across 1 country: China