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

NCT04704492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Biological: SM03

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

Sponsors & Collaborators

  • SinoMab BioScience Ltd

    lead INDUSTRY

Principal Investigators

  • Pei Hu, PhD,MD · Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-08-14
Primary Completion
2013-12-16
Completion
2013-12-16

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 NCT04704492 on ClinicalTrials.gov