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Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis

NCT02480946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2017-03-28

No results posted yet for this study

Summary

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly inhibit bone damage.The aim of this study is to test the safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in combination with an existing treatment, methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

MBS2320

As described in the arm descriptions

DRUG

Placebo

As described in the arm descriptions

DRUG

Methotrexate

Background therapy as described in the arm descriptions

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Modern Biosciences Ltd

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB,PhD · Covance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02480946 on ClinicalTrials.gov